xml: <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/NCT05974566</url>
    </required_header>
    <id_info>
      <org_study_id>2023-07</org_study_id>
      <nct_id>NCT05974566</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction</brief_title>
    <official_title>Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chongqing Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA),&#xD;
        nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease&#xD;
        (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients&#xD;
        with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In&#xD;
        patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and&#xD;
        cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart&#xD;
        failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is&#xD;
        still no real world study on finerenone in patients with heart failure with reduced ejection&#xD;
        fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM&#xD;
        and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of&#xD;
        finerenone in HFrEF patients compared to other MRAs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)</measure>
      <time_frame>before and after 6 months of medication</time_frame>
      <description>The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Composite endpoint of death and heart failure rehospitalization</measure>
      <time_frame>during the 6-month period of medication therapy</time_frame>
      <description>The composite endpoint include the death due to cardiovascular reasons, worsening of renal disease, rehospitalization due to heart failure and admission to hospital to accept intravenous diuretics therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in left ventricular ejection fraction (LVEF)</measure>
      <time_frame>before and after 6 months of medication</time_frame>
      <description>The change in LVEF measured by echocardiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in extracellular volume (ECV)</measure>
      <time_frame>Before and after 3 months of continuous treatment</time_frame>
      <description>Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in renal function level</measure>
      <time_frame>Before and after 3 months of continuous treatment</time_frame>
      <description>Change in estimated glomerular filtration rate(eGFR) reflect the renal function</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Diabetic Nephropathies</condition>
    <arm_group>
      <arm_group_label>HFrEF patients who accept finerenone therapy</arm_group_label>
      <description>Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFrEF patients who accept Spironolactone or eplerenone therapy</arm_group_label>
      <description>Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with heart failure with reduced ejection fraction and NYHA classes II-IV&#xD;
          with or without diabetic nephropathy will be incorporated in the study, and other patients&#xD;
          who are unable to tolerant treatment will be excluded&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  New York Heart Association(NYHA) functional classification II - IV&#xD;
  &#xD;
            -  LVEF measured by the echocardiogram ≤ 45%&#xD;
  &#xD;
            -  eGFR&gt;25mL/min/1.73m²&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  LVEF measured by the echocardiogram &gt; 45%&#xD;
  &#xD;
            -  History of allergic or hypersensitivity to drugs involved in the trial.&#xD;
  &#xD;
            -  Patients with a known history of cancer, angioedema, significant congenital heart&#xD;
               disease or rheumatic heart disease.&#xD;
  &#xD;
            -  Patients diagnosed with myocarditis.&#xD;
  &#xD;
            -  Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD,&#xD;
               bronchial asthma, primary pulmonary hypertension.&#xD;
  &#xD;
            -  Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP)&#xD;
  &#xD;
                 -  120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.&#xD;
  &#xD;
            -  Patients with cardiac pacemaker&#xD;
  &#xD;
            -  Pregnant woman&#xD;
  &#xD;
            -  eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy.&#xD;
  &#xD;
            -  Serum potassium &gt;5.2 mmol/l at visit&#xD;
  &#xD;
            -  Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular&#xD;
               tachycardia, ventricular rate&gt;150 bpm in AF patients.&#xD;
  &#xD;
            -  Obvious stenosis (≥50%) of bilateral renal arteries.&#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>Dongying Zhang, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dongying Zhang, PhD</last_name>
      <phone>+86-13608398395</phone>
      <email>zdy.chris@qq.com</email>
    </overall_contact>
    <results_reference>
      <citation>Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.</citation>
      <PMID>34449181</PMID>
    </results_reference>
    <results_reference>
      <citation>Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.</citation>
      <PMID>33264825</PMID>
    </results_reference>
    <results_reference>
      <citation>Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.</citation>
      <PMID>27130705</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Dongying Zhang</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Nephropathies</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974566
  org study id: 2023-07
  nct id: NCT05974566
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA),
        nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease
        (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients
        with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In
        patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and
        cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart
        failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is
        still no real world study on finerenone in patients with heart failure with reduced ejection
        fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM
        and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of
        finerenone in HFrEF patients compared to other MRAs.
  observational model: Cohort
  time perspective: Retrospective
  measure: Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
  time frame: before and after 6 months of medication
  description: The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure
  measure: Composite endpoint of death and heart failure rehospitalization
  time frame: during the 6-month period of medication therapy
  description: The composite endpoint include the death due to cardiovascular reasons, worsening of renal disease, rehospitalization due to heart failure and admission to hospital to accept intravenous diuretics therapy
  measure: Change in left ventricular ejection fraction (LVEF)
  time frame: before and after 6 months of medication
  description: The change in LVEF measured by echocardiogram
  measure: Change in extracellular volume (ECV)
  time frame: Before and after 3 months of continuous treatment
  description: Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis
  measure: Change in renal function level
  time frame: Before and after 3 months of continuous treatment
  description: Change in estimated glomerular filtration rate(eGFR) reflect the renal function
  arm group label: HFrEF patients who accept finerenone therapy
  description: Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications.
  arm group label: HFrEF patients who accept Spironolactone or eplerenone therapy
  description: Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dongying Zhang, PhD
  role: Study Chair
  affiliation: First Affiliated Hospital of Chongqing Medical University
  last name: Dongying Zhang, PhD
  phone: +86-13608398395
  email: zdy.chris@qq.com
  citation: Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
  PMID: 34449181
  citation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.
  PMID: 33264825
  citation: Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.
  PMID: 27130705
  responsible party type: Principal Investigator
  investigator affiliation: Chongqing Medical University
  investigator full name: Dongying Zhang
  investigator title: Director
  mesh term: Diabetic Nephropathies
  mesh term: Heart Failure
  sharing ipd: No