<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03030235</url>
  </required_header>
  <id_info>
    <org_study_id>D1690C00053</org_study_id>
    <nct_id>NCT03030235</nct_id>
  </id_info>
  <brief_title>Dapagliflozin in PRESERVED Ejection Fraction Heart Failure</brief_title>
  <acronym>PRESERVED-HF</acronym>
  <official_title>Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With PRESERVED Ejection Fraction Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Luke's Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Luke's Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared&#xD;
      with placebo, on heart failure, disease specific biomarkers, symptoms, health status and&#xD;
      quality of life in patients with chronic heart failure with preserved systolic function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of&#xD;
      once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (NTproBNP and&#xD;
      BNP), symptoms, health status, and quality of life in patients with chronic heart failure&#xD;
      with preserved systolic function. An imaging substudy will also be conducted to explore the&#xD;
      effects of dapagliflozin vs. placebo on various echocardiographic parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">August 13, 2021</completion_date>
  <primary_completion_date type="Actual">August 13, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Weight</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">324</enrollment>
  <condition>Chronic Heart Failure With Preserved Systolic Function</condition>
  <arm_group>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin 10Mg Oral Tablet</intervention_name>
    <description>Dapagliflozin 10Mg Oral Tablet</description>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <other_name>Farxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin matching placebo</intervention_name>
    <description>Dapagliflozin matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo Oral Tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic&#xD;
             explanation for dyspnea&#xD;
&#xD;
          2. Ejection fraction (EF) ≥ 45% as determined on imaging study within 24 months of&#xD;
             enrolment with no change in clinical status suggesting potential for deterioration in&#xD;
             systolic function&#xD;
&#xD;
          3. Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml). For patients with permanent&#xD;
             atrial fibrillation inclusion thresholds will be BNP ≥ 100 pg/mL or NTproBNP ≥ 375&#xD;
             pg/mL&#xD;
&#xD;
          4. Stable medical therapy for heart failure for 15 days as defined by: i. No addition or&#xD;
             removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril,&#xD;
             beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists; ii.No&#xD;
             substantial change in dosage (100% or greater increase or decrease from baseline dose)&#xD;
             of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists&#xD;
&#xD;
          5. On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7&#xD;
             days&#xD;
&#xD;
          6. At least one of the following: i. Hospitalization for decompensated HF in the last 12&#xD;
             months; ii. Acute treatment for HF with intravenous loop diuretic or hemofiltration in&#xD;
             the last 12 months; iii. Mean pulmonary capillary wedge pressure ≥15 mmHg or LV end&#xD;
             diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest, or&#xD;
             pulmonary capillary wedge pressure or LVEDP ≥25 mmHg documented during catheterization&#xD;
             with exercise; iv. Structural heart disease evidenced by at least one of the following&#xD;
             echo findings (any local measurement made within the 24 months prior to screening&#xD;
             visit): a) left atrial (LA) enlargement defined by at least one of the following: LA&#xD;
             width ≥3.8cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 mL or LA volume&#xD;
             index ≥29 mL/m2 b) or left ventricular hypertrophy (LVH) defined by septal thickness&#xD;
             or posterior wall thickness ≥1.1 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decompensated heart failure (hospitalization for heart failure within 7 days prior to&#xD;
             screening)&#xD;
&#xD;
          2. History of type 1 diabetes&#xD;
&#xD;
          3. History of diabetic ketoacidosis&#xD;
&#xD;
          4. Estimated glomerular filtration rate (eGFR) &lt; 20 at the screening visit by modified&#xD;
             MDRD equation GFR (mL/min/1.73 m2 ) = 175 x (Scr) -1.154 x (Age)-0.203 x (0.742 if&#xD;
             female) x (1.210 if African American)&#xD;
&#xD;
          5. Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or&#xD;
             unstable angina), percutaneous coronary intervention, or cardiac surgery within 30&#xD;
             days prior to the screening visit.&#xD;
&#xD;
          6. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the&#xD;
             screening visit.&#xD;
&#xD;
          7. Planned cardiovascular revascularization (percutaneous intervention or surgical) or&#xD;
             major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular&#xD;
             assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or&#xD;
             transcatheter aortic valve replacement) or CRT within the 90 days after the screening&#xD;
             visit.&#xD;
&#xD;
          8. Participation in any interventional clinical trial (with an investigational drug or&#xD;
             device) that is not an observational registry within 15 days of the screening visit.&#xD;
&#xD;
          9. History of hypersensitivity to dapagliflozin&#xD;
&#xD;
         10. For women of child-bearing potential: Current or planned pregnancy or currently&#xD;
             lactating.&#xD;
&#xD;
         11. Life expectancy &lt;1 year at the screening visit&#xD;
&#xD;
         12. Patients who are volume depleted based upon physical examination at the time of the&#xD;
             screening or randomization visit&#xD;
&#xD;
         13. BNP &lt;75 pg/mL and NTproBNP&lt;225 pg/mL at the screening visit. For patients with&#xD;
             permanent atrial fibrillation exclusion thresholds will be BNP&lt;100 pg/mL and&#xD;
             NTproBNP&lt;375pg/mL.&#xD;
&#xD;
         14. Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin,&#xD;
             canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any&#xD;
             SGLT-2 inhibitor within the 12 weeks prior to the screening visit.&#xD;
&#xD;
         15. Average supine systolic BP &lt;100 mmHg at the screening or randomization visit&#xD;
&#xD;
         16. Current history of bladder cancer&#xD;
&#xD;
         17. Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned&#xD;
             donations during the study period&#xD;
&#xD;
         18. Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis,&#xD;
             constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic&#xD;
             obstructive cardiomyopathy).&#xD;
&#xD;
         19. Heart failure due to severe aortic or mitral regurgitation&#xD;
&#xD;
         20. Severe COPD thought to be a primary contributor to dyspnea&#xD;
&#xD;
         21. Isolated right heart failure due to pulmonary disease&#xD;
&#xD;
         22. Active and significant ischemia thought to be a primary contributor to dyspnea&#xD;
&#xD;
         23. Documentation of previous EF &lt; 45%, under stable conditions, within the past 36 months&#xD;
&#xD;
         24. Complex congenital heart disease&#xD;
&#xD;
         25. Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the&#xD;
             screening visit (average value of three blood pressure measurements obtained in supine&#xD;
             position)&#xD;
&#xD;
         26. Any other condition that in the judgment of the investigator would jeopardize the&#xD;
             patient's participation in the study or that may interfere with the interpretation of&#xD;
             study data or if the patient is considered unlikely to comply with study procedures,&#xD;
             restrictions and requirements&#xD;
&#xD;
         27. Bariatric surgery within the past 6 months or planned bariatric surgery within the&#xD;
             study time course.&#xD;
&#xD;
         28. CardioMems device implantation within previous 4 weeks or planned CardioMems&#xD;
             implantation during study period&#xD;
&#xD;
         29. For echo substudy only: patients with ventricular paced rhythm or left bundle branch&#xD;
             block on the most recent clinically available 12-lead electrocardiogram.&#xD;
&#xD;
         30. For echo substudy only: permanent atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>119 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikhail Kosiborod, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Saint Luke's Mid America Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Group of the Eastern Shore</name>
      <address>
        <city>Fairhope</city>
        <state>Alabama</state>
        <zip>36532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Coast Cardiovascular Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Heart Group Research Center</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem Research Insititute</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Medical Research</name>
      <address>
        <city>Hazel Crest</city>
        <state>Illinois</state>
        <zip>60429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF HealthCare Cardiovascular Institute</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Cardiovascular Research Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Clinical Research Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Mid America Heart Institute</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Nephrology Associates</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://druginfo.nlm.nih.gov/drugportal/name/dapagliflozin</url>
    <description>Dapagliflozin information</description>
  </link>
  <results_reference>
    <citation>Nassif ME, Windsor SL, Borlaug BA, Kitzman DW, Shah SJ, Tang F, Khariton Y, Malik AO, Khumri T, Umpierrez G, Lamba S, Sharma K, Khan SS, Chandra L, Gordon RA, Ryan JJ, Chaudhry SP, Joseph SM, Chow CH, Kanwar MK, Pursley M, Siraj ES, Lewis GD, Clemson BS, Fong M, Kosiborod MN. The SGLT2 inhibitor dapagliflozin in heart failure with preserved ejection fraction: a multicenter randomized trial. Nat Med. 2021 Nov;27(11):1954-1960. doi: 10.1038/s41591-021-01536-x. Epub 2021 Oct 28.</citation>
    <PMID>34711976</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>August 11, 2022</results_first_submitted>
  <results_first_submitted_qc>September 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2022</results_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>dapagliflozin</keyword>
  <keyword>SGLT-2 inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03030235/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03030235/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="146"/>
                <participants group_id="P2" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="162"/>
            <count group_id="B2" value="162"/>
            <count group_id="B3" value="324"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69" lower_limit="64" upper_limit="77"/>
                    <measurement group_id="B2" value="71" lower_limit="63" upper_limit="78"/>
                    <measurement group_id="B3" value="70" lower_limit="63" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                    <measurement group_id="B2" value="162"/>
                    <measurement group_id="B3" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Heart Failure</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" lower_limit="1.1" upper_limit="6.5"/>
                    <measurement group_id="B2" value="3.2" lower_limit="1.0" upper_limit="6.6"/>
                    <measurement group_id="B3" value="3.0" lower_limit="1.0" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous Hospitalization for Heart Failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ejection Fraction</title>
          <description>Ejection fraction is measured as a percentage of the total amount of blood in the heart that is pumped out with each heartbeat.</description>
          <units>percent</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="55" upper_limit="65"/>
                    <measurement group_id="B2" value="60" lower_limit="54" upper_limit="65"/>
                    <measurement group_id="B3" value="60" lower_limit="55" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ischemic Heart Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type 2 Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atrial Fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Internal Cardiac Defibrillator (ICD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiotensin converting enzyme inhibitor (ACEI) / Angiotensin II receptor blocker (ARB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiotensin receptor-neprilysin inhibitor (ARNI)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beta-blockers</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hydralazine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Long-Acting Nitrates</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mineralocorticoid receptor agonist (MRA)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Loop Diuretics</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lipid-Lowering Agents</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anticoagulant Agents</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.1" lower_limit="30.4" upper_limit="41.8"/>
                    <measurement group_id="B2" value="34.6" lower_limit="29.7" upper_limit="40.4"/>
                    <measurement group_id="B3" value="34.7" lower_limit="30.1" upper_limit="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart Rate</title>
          <units>beats per minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="61" upper_limit="77"/>
                    <measurement group_id="B2" value="68" lower_limit="62" upper_limit="75"/>
                    <measurement group_id="B3" value="68" lower_limit="62" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mm Hg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134" lower_limit="120" upper_limit="152"/>
                    <measurement group_id="B2" value="132" lower_limit="118" upper_limit="148"/>
                    <measurement group_id="B3" value="133" lower_limit="120" upper_limit="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-terminal pro B-type natriuretic peptide (NT-proBNP) - overall</title>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="641" lower_limit="373" upper_limit="1210"/>
                    <measurement group_id="B2" value="710" lower_limit="329" upper_limit="1449"/>
                    <measurement group_id="B3" value="671" lower_limit="355" upper_limit="1297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-terminal pro B-type natriuretic peptide (NT-proBNP) - participants with atrial fibrillation</title>
          <population>The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="89"/>
                    <count group_id="B3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="830" lower_limit="555" upper_limit="1711"/>
                    <measurement group_id="B2" value="816" lower_limit="481" upper_limit="1687"/>
                    <measurement group_id="B3" value="816" lower_limit="507" upper_limit="1693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-terminal pro B-type natriuretic peptide (NT-proBNP) - participants with no atrial fibrillation</title>
          <population>The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="73"/>
                    <count group_id="B3" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="438" lower_limit="269" upper_limit="750"/>
                    <measurement group_id="B2" value="485" lower_limit="263" upper_limit="1168"/>
                    <measurement group_id="B3" value="459" lower_limit="266" upper_limit="868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Brain Natriuretic Peptide (BNP) - overall</title>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137" lower_limit="81" upper_limit="222"/>
                    <measurement group_id="B2" value="151" lower_limit="90" upper_limit="254"/>
                    <measurement group_id="B3" value="142" lower_limit="85" upper_limit="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Brain Natriuretic Peptide (BNP) - participants with atrial fibrillation</title>
          <population>The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="89"/>
                    <count group_id="B3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169" lower_limit="109" upper_limit="255"/>
                    <measurement group_id="B2" value="151" lower_limit="104" upper_limit="258"/>
                    <measurement group_id="B3" value="154" lower_limit="107" upper_limit="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Brain Natriuretic Peptide (BNP) - participants with no atrial fibrillation</title>
          <population>The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="73"/>
                    <count group_id="B3" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107" lower_limit="67" upper_limit="179"/>
                    <measurement group_id="B2" value="161" lower_limit="77" upper_limit="241"/>
                    <measurement group_id="B3" value="128" lower_limit="71" upper_limit="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated glomerular filtration rate (eGFR)</title>
          <units>mL/minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="42" upper_limit="69"/>
                    <measurement group_id="B2" value="54" lower_limit="41" upper_limit="69"/>
                    <measurement group_id="B3" value="55" lower_limit="41" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c</title>
          <units>percent of glycosylated hemoglobin</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0" lower_limit="5.6" upper_limit="7.3"/>
                    <measurement group_id="B2" value="6.2" lower_limit="5.6" upper_limit="7.1"/>
                    <measurement group_id="B3" value="6.1" lower_limit="5.6" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin</title>
          <units>g/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.7" lower_limit="11.5" upper_limit="13.9"/>
                    <measurement group_id="B2" value="12.6" lower_limit="11.6" upper_limit="13.8"/>
                    <measurement group_id="B3" value="12.6" lower_limit="11.5" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Class II</title>
          <description>NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity. A higher class means a worse functional condition. NYHA Class II indicates the patient has been classified as having slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Class III/IV</title>
          <description>NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity A higher class means a worse functional condition. NYHA Class III indicates the patient has been classified as having marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA Class IV indicates the patient has been classified Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS)</title>
          <description>The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.2" spread="20.4"/>
                    <measurement group_id="B2" value="62.3" spread="20.6"/>
                    <measurement group_id="B3" value="62.7" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS)</title>
          <description>The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.4" spread="19.7"/>
                    <measurement group_id="B2" value="61.8" spread="20.3"/>
                    <measurement group_id="B3" value="62.6" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>6 minute walk test</title>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="162"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="244" lower_limit="165" upper_limit="329"/>
                    <measurement group_id="B2" value="244" lower_limit="154" upper_limit="317"/>
                    <measurement group_id="B3" value="244" lower_limit="162" upper_limit="326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)</title>
        <description>Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)</title>
          <description>Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.6" lower_limit="66.2" upper_limit="71.0"/>
                    <measurement group_id="O2" value="62.8" lower_limit="60.4" upper_limit="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)</title>
        <description>Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)</title>
          <description>Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.9" lower_limit="66.5" upper_limit="71.3"/>
                    <measurement group_id="O2" value="64.5" lower_limit="62.1" upper_limit="66.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</title>
        <description>NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</title>
          <description>NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="733" lower_limit="673" upper_limit="799"/>
                    <measurement group_id="O2" value="739" lower_limit="678" upper_limit="805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)</title>
        <description>BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)</title>
          <description>BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147" lower_limit="136" upper_limit="160"/>
                    <measurement group_id="O2" value="147" lower_limit="136" upper_limit="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance</title>
        <description>6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance</title>
          <description>6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="262" lower_limit="252" upper_limit="272"/>
                    <measurement group_id="O2" value="242" lower_limit="232" upper_limit="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c</title>
        <description>Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c</title>
          <description>Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="6.4" upper_limit="6.6"/>
                    <measurement group_id="O2" value="6.6" lower_limit="6.5" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)</title>
        <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)</title>
          <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12.&#xD;
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.&#xD;
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>KCCQ-CS increase ≥ 5 points</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KCCQ-OS increase ≥ 5 points</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</title>
        <description>Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)</title>
          <description>Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)</title>
        <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)</title>
          <description>Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <population>The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Weight</title>
        <description>Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Weight</title>
          <description>Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.3" lower_limit="100.9" upper_limit="101.8"/>
                    <measurement group_id="O2" value="102.1" lower_limit="101.6" upper_limit="102.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure</title>
        <description>Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure</title>
          <description>Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" lower_limit="130" upper_limit="135"/>
                    <measurement group_id="O2" value="133" lower_limit="131" upper_limit="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period.</time_frame>
      <desc>Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks&#xD;
Dapagliflozin matching placebo: Dapagliflozin matching placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Elective Watchman Device Implantation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Exacerbation of Heart Failure</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Iron Overload cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Aortic Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Type II NSTEMI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bleed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Acute Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Acute Right Cerebellar Infarct</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Benign Paroxysmal Positional Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Critical Limb Ischemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Elevated Troponin in the setting of Covid-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Exacerbation of Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hemochromatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hypercapnic and hypoxic respiratory failure requiring intubation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Melena and hematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Non cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Renal failure leading to endstage renal disease requiring dialysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Endstage chronic obstructive pulmonary disease with hypoxic and hypercapnic respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Uncontrolled Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Volume Depletion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites of the Abdomen</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Liver failure/Cirrhosis leading to Hepatic/Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Infected right great toe</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Influenza A</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Multiple Abscesses</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Parainfluenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Right Shoulder - Infected Arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Salmonella enteritis/diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Septic Arthritis of the Right Knee</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Septicemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal Wall Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Left hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis (Right Hip)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Osteomyelitis (left foot)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Right leg pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Worsening Osteoarthritis - Left Knee</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Left hilar mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Schwannoma of spinal cord at L1-L2</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Urgent Heart Failure Visit</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Volume Depletion</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Blurry vision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Shortness of Breath</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Foul smelling urine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Sense of hopelessness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Leg pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor will have 18 months after the study closure to arrange for the submission of multicenter publications. If multicenter publications are not submitted within 24 months after conclusion of the study, PI may publish the results from their site's data, pursuant to approval by the Sponsor and Executive Committee at least 60 days prior to submission. The Sponsor cannot require changes to the communication with the exception of requiring the removal of confidential information.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>PRESERVED-HF Study Manager</name_or_title>
      <organization>Saint Luke's Hospital of Kansas City</organization>
      <phone>816-932-9858</phone>
      <email>PRESERVED-HF@saint-lukes.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03030235
org study id: D1690C00053
nct id: NCT03030235
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
      with placebo, on heart failure, disease specific biomarkers, symptoms, health status and
      quality of life in patients with chronic heart failure with preserved systolic function.
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of
      once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (NTproBNP and
      BNP), symptoms, health status, and quality of life in patients with chronic heart failure
      with preserved systolic function. An imaging substudy will also be conducted to explore the
      effects of dapagliflozin vs. placebo on various echocardiographic parameters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)
time frame: Baseline to Week 12
description: Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12.
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points.
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
time frame: Baseline to Week 12
description: Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12.
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
time frame: Baseline to Week 12
description: NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)
time frame: Baseline to Week 12
description: BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance
time frame: Baseline to Week 12
description: 6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c
time frame: Baseline to Week 12
description: Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)
time frame: Baseline to Week 12
description: Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12.
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
time frame: Baseline to Week 12
description: Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)
time frame: Baseline to Week 12
description: Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Weight
time frame: Baseline to Week 12
description: Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
measure: Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure
time frame: Baseline to Week 12
description: Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
arm group label: Dapagliflozin
arm group type: Active Comparator
description: Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks
intervention type: Drug
intervention name: Dapagliflozin 10Mg Oral Tablet
description: Dapagliflozin 10Mg Oral Tablet
arm group label: Dapagliflozin
other name: Farxiga
intervention type: Drug
intervention name: Dapagliflozin matching placebo
description: Dapagliflozin matching placebo
arm group label: Placebo
other name: Placebo Oral Tablet
criteria: 
gender: All
minimum age: 19 Years
maximum age: 119 Years
healthy volunteers: No
last name: Mikhail Kosiborod, MD
role: Study Chair
affiliation: Saint Luke's Mid America Heart Institute
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country: United States
url: https://druginfo.nlm.nih.gov/drugportal/name/dapagliflozin
description: Dapagliflozin information
citation: Nassif ME, Windsor SL, Borlaug BA, Kitzman DW, Shah SJ, Tang F, Khariton Y, Malik AO, Khumri T, Umpierrez G, Lamba S, Sharma K, Khan SS, Chandra L, Gordon RA, Ryan JJ, Chaudhry SP, Joseph SM, Chow CH, Kanwar MK, Pursley M, Siraj ES, Lewis GD, Clemson BS, Fong M, Kosiborod MN. The SGLT2 inhibitor dapagliflozin in heart failure with preserved ejection fraction: a multicenter randomized trial. Nat Med. 2021 Nov;27(11):1954-1960. doi: 10.1038/s41591-021-01536-x. Epub 2021 Oct 28.
PMID: 34711976
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Dapagliflozin
sharing ipd: No
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