<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/NCT03296813</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00080595</org_study_id>
    <secondary_id>U01HL125511-01A1</secondary_id>
    <nct_id>NCT03296813</nct_id>
  </id_info>
  <brief_title>TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure</brief_title>
  <acronym>TRANSFORM-HF</acronym>
  <official_title>TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study&#xD;
      comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000&#xD;
      patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study&#xD;
      is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over&#xD;
      12 months in patients with heart failure who are hospitalized.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  This study will be a randomized, unblinded, two-arm, multi-center clinical trial of&#xD;
           patients with heart failure who are hospitalized. Heart failure need not be the reason&#xD;
           for hospitalization. Patients will be randomized 1:1 to either oral torsemide OR oral&#xD;
           furosemide prior to hospital discharge. Oral dosing of torsemide compared to furosemide&#xD;
           will be 1mg:2mg. The specific loop diuretic dose will be at the discretion of the&#xD;
           treating physician with the above noted conversion.&#xD;
&#xD;
        -  Trial enrollment occurs before hospital discharge, at the discretion of the healthcare&#xD;
           provider.&#xD;
&#xD;
        -  As appropriate, adherence to the randomized medication will be encouraged during the&#xD;
           remainder of hospitalization and will continue post-discharge. Patients will receive&#xD;
           follow-up per standard care without any additional study-specific visits.&#xD;
&#xD;
        -  Patients will have 30-day, 6-month and 12-month follow-up phone contacts for assessments&#xD;
           of vital status, interval hospitalizations, adherence, and quality of life. &quot;Central&#xD;
           follow-up&quot; and collection of hospital discharge summaries via IRB-approved mechanisms.&#xD;
           Subsets of patients enrolled early in the study have additional phone contacts beyond 12&#xD;
           months, up to 30 months, at six month intervals, to document vital status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Actual">July 29, 2022</completion_date>
  <primary_completion_date type="Actual">July 29, 2022</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality, as measured by follow-up phone call</measure>
    <time_frame>30 months</time_frame>
    <description>All-cause mortality over a follow-up period of 12 months; subsets of patients to be evaluated at 6 month intervals to document vital status up to 30 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality or all-cause hospitalization, as measured by follow-up phone call</measure>
    <time_frame>12 months</time_frame>
    <description>All-cause mortality or all-cause hospitalization over 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospitalizations, as measured by follow-up phone call</measure>
    <time_frame>12 months</time_frame>
    <description>Total hospitalizations over 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality or all-cause hospitalization, as measured by follow-up phone call</measure>
    <time_frame>30 days</time_frame>
    <description>All-cause mortality or all-cause hospitalization over 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life, as measured by follow-up phone call</measure>
    <time_frame>12 months</time_frame>
    <description>Health-related quality of life over 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of depression, as measured by follow-up phone call</measure>
    <time_frame>12 months</time_frame>
    <description>Symptoms of depression over 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2859</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Torsemide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Furosemide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.&#xD;
For patients receiving loop diuretics other than furosemide, conversion to furosemide equivalents will be as follows:&#xD;
1 mg oral torsemide = 2-4 mg oral furosemide&#xD;
1 mg oral or intravenous bumetanide = 40 mg oral furosemide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Torsemide</intervention_name>
    <description>Loop diuretic</description>
    <arm_group_label>Torsemide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Furosemide</intervention_name>
    <description>Loop diuretic</description>
    <arm_group_label>Furosemide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient hospitalized (≥ 24 hours or over a change in calendar date) with worsening of&#xD;
             chronic heart failure, or new diagnosis of heart failure AND meets one of the&#xD;
             following criteria:&#xD;
&#xD;
               1. Has a left ventricular ejection fraction (EF) ≤40% within 24 months prior to and&#xD;
                  including index hospitalization by any method (with most recent value used to&#xD;
                  determine eligibility)&#xD;
&#xD;
               2. Has an elevated natriuretic peptide level (either NT-pro-B-type natriuretic&#xD;
                  peptide or B-type natriuretic peptide) during index hospitalization as measured&#xD;
                  by local laboratory (with most recent value used to determine eligibility)&#xD;
&#xD;
          2. Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with&#xD;
             anticipated need for long-term loop diuretic use&#xD;
&#xD;
          3. ≥ 18 years of age&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. End-stage renal disease requiring renal replacement therapy&#xD;
&#xD;
          2. Inability or unwillingness to comply with the study requirements&#xD;
&#xD;
          3. History of heart transplant or actively listed for heart transplant&#xD;
&#xD;
          4. Implanted left ventricular assist device or implant anticipated &lt;3 months&#xD;
&#xD;
          5. Pregnant or nursing women&#xD;
&#xD;
          6. Malignancy or other non-cardiac condition limiting life expectancy to &lt;12 months&#xD;
&#xD;
          7. Known hypersensitivity to furosemide, torsemide, or related agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Velazquez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Mentz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Russel Medical Center</name>
      <address>
        <city>Alexander City</city>
        <state>Alabama</state>
        <zip>35010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Center, PC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.A. Greater Los Angeles Healthcare System</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital and Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Haven VA Medical Center</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Health Care</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Valley Clinical Research Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Bloomington Hospital</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oschner Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center/University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shady Grove Medical Center</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Health System / Michigan Heart</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>29216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lester E. Cox Health Systems</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AtlantiCare Regional Medical Center</name>
      <address>
        <city>Pomona</city>
        <state>New Jersey</state>
        <zip>08240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefore Medical Center - Albert Einstein University Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian/Brooklyn Methodist Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029-6574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina School of Medicine</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke (Duke Heart Center)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Matthews Medical Center</name>
      <address>
        <city>Matthews</city>
        <state>North Carolina</state>
        <zip>28240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hanover Regional Medical Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital</name>
      <address>
        <city>Ephrata</city>
        <state>Pennsylvania</state>
        <zip>17522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University College of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Main Line Health System</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System University Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Cardiovascular Research</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospitals and Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Health Care Services</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Health</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://dcri.org</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://transformhfstudy.org</url>
    <description>TRANSFORM-HF study website</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>loop diuretic</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>Torsemide</mesh_term>
    <mesh_term>Furosemide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03296813/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 28, 2023</submitted>
    <returned>August 21, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03296813
org study id: Pro00080595
secondary id: U01HL125511-01A1
nct id: NCT03296813
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study
      comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000
      patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study
      is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over
      12 months in patients with heart failure who are hospitalized.
-  This study will be a randomized, unblinded, two-arm, multi-center clinical trial of
           patients with heart failure who are hospitalized. Heart failure need not be the reason
           for hospitalization. Patients will be randomized 1:1 to either oral torsemide OR oral
           furosemide prior to hospital discharge. Oral dosing of torsemide compared to furosemide
           will be 1mg:2mg. The specific loop diuretic dose will be at the discretion of the
           treating physician with the above noted conversion.

        -  Trial enrollment occurs before hospital discharge, at the discretion of the healthcare
           provider.

        -  As appropriate, adherence to the randomized medication will be encouraged during the
           remainder of hospitalization and will continue post-discharge. Patients will receive
           follow-up per standard care without any additional study-specific visits.

        -  Patients will have 30-day, 6-month and 12-month follow-up phone contacts for assessments
           of vital status, interval hospitalizations, adherence, and quality of life. "Central
           follow-up" and collection of hospital discharge summaries via IRB-approved mechanisms.
           Subsets of patients enrolled early in the study have additional phone contacts beyond 12
           months, up to 30 months, at six month intervals, to document vital status.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge.
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality, as measured by follow-up phone call
time frame: 30 months
description: All-cause mortality over a follow-up period of 12 months; subsets of patients to be evaluated at 6 month intervals to document vital status up to 30 months.
measure: All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
time frame: 12 months
description: All-cause mortality or all-cause hospitalization over 12 months
measure: Total hospitalizations, as measured by follow-up phone call
time frame: 12 months
description: Total hospitalizations over 12 months
measure: All-cause mortality or all-cause hospitalization, as measured by follow-up phone call
time frame: 30 days
description: All-cause mortality or all-cause hospitalization over 30 days
measure: Health-related quality of life, as measured by follow-up phone call
time frame: 12 months
description: Health-related quality of life over 12 months
measure: Symptoms of depression, as measured by follow-up phone call
time frame: 12 months
description: Symptoms of depression over 12 months
arm group label: Torsemide
arm group type: Active Comparator
description: Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
arm group label: Furosemide
arm group type: Active Comparator
description: Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
For patients receiving loop diuretics other than furosemide, conversion to furosemide equivalents will be as follows:
1 mg oral torsemide = 2-4 mg oral furosemide
1 mg oral or intravenous bumetanide = 40 mg oral furosemide
intervention type: Drug
intervention name: Torsemide
description: Loop diuretic
arm group label: Torsemide
intervention type: Drug
intervention name: Furosemide
description: Loop diuretic
arm group label: Furosemide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Velazquez, MD
role: Principal Investigator
affiliation: Yale University
last name: Robert Mentz, MD
role: Principal Investigator
affiliation: Duke University
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country: United States
url: http://dcri.org
description: Related Info
url: http://transformhfstudy.org
description: TRANSFORM-HF study website
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Torsemide
mesh term: Furosemide
sharing ipd: No
provided document: 
submitted: July 28, 2023
returned: August 21, 2023