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/NCT06008197</url>
    </required_header>
    <id_info>
      <org_study_id>202301CPC</org_study_id>
      <nct_id>NCT06008197</nct_id>
    </id_info>
    <brief_title>A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients</brief_title>
    <acronym>REDEFINE-HF</acronym>
    <official_title>Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Colorado Prevention Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Saint Luke's Hospital of Kansas City</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bayer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Colorado Prevention Center</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Finerenone will be compared to placebo to determine efficacy and safety of treatment in&#xD;
        patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or&#xD;
        preserved left ventricular ejection fraction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an international, randomized, double-blind, placebo-controlled, event-driven trial of&#xD;
        finerenone for the treatment hospitalized heart failure patients with mildly reduced or&#xD;
        preserved ejection fraction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">April 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2026</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Composite total of HF events and cardiovascular (CV) death.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of serious adverse events.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of adverse events leading to discontinuation of study drug.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to first occurrence of the composite of CV death or HF event.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total HF events.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Total HF events with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.</measure>
      <time_frame>6 Months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to CV death.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Time to CV death with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to death from any cause.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Time to death from any cause with finerenone compared to placebo.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Total hospitalizations for any cause.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Total hospitalizations for any cause with finerenone compared to placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Total number of days alive and out of the hospital.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Days alive and out of hospital with finerenone compared to placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of patients with sustained decrease in eGFR ≥40% relative to baseline.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Sustained decrease in eGFR ≥40% relative to baseline with finerenone compared to placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of patients with sustained eGFR &lt;15 ml/min/1.73 m^2.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Sustained eGFR &lt;15 ml/min/1.73 m^2 with finerenone compared to placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of patients requiring initiation of dialysis or renal transplant.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Initiation of dialysis or renal transplant with finerenone compared to placebo.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">5200</enrollment>
    <condition>Heart Failure</condition>
    <condition>Acute Heart Failure</condition>
    <arm_group>
      <arm_group_label>Finerenone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Finerenone</intervention_name>
      <description>Oral finerenone</description>
      <arm_group_label>Finerenone</arm_group_label>
      <other_name>Kerendia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching oral placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide electronic or written informed consent, either personally or through a legally&#xD;
               authorized representative&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Current hospitalization or recently discharged with the primary diagnosis of heart&#xD;
               failure&#xD;
  &#xD;
            -  Heart failure signs and symptoms at the time of hospital admission&#xD;
  &#xD;
            -  Imaging evidence of mildly reduced or preserved left ventricular ejection fraction&#xD;
               (EF) (40% or higher)&#xD;
  &#xD;
            -  Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type&#xD;
               natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or&#xD;
               elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Treatment with a mineralocorticoid receptor antagonist (MRA)&#xD;
  &#xD;
            -  Documented prior history of severe hyperkalemia in the setting of MRA use&#xD;
  &#xD;
            -  Estimated glomerular filtration rate (eGFR) &lt;25 mL/min/1.73m² or serum/plasma&#xD;
               potassium &gt;5.0 mmol/L at screening&#xD;
  &#xD;
            -  Acute myocardial infarction, coronary revascularization, valve replacement/repair, or&#xD;
               implantation of a cardiac resynchronization therapy device within 30 days&#xD;
  &#xD;
            -  Hemodynamically significant (severe) uncorrected primary cardiac valvular disease&#xD;
  &#xD;
            -  Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases,&#xD;
               accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes,&#xD;
               known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or&#xD;
               known pericardial constriction&#xD;
  &#xD;
            -  Probable alternative cause of participant's heart failure symptoms&#xD;
  &#xD;
            -  Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)&#xD;
               inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers&#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_contact>
      <last_name>Marc Bonaca</last_name>
      <phone>303-860-9900</phone>
      <email>info@cpcmed.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heart failure</keyword>
    <keyword>Preserved ejection fraction</keyword>
    <keyword>Mildly reduced ejection fraction</keyword>
    <keyword>Hospitalized</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No current plan to share individual patient data with other researchers.</ipd_description>
    </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/NCT06008197
  org study id: 202301CPC
  nct id: NCT06008197
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Finerenone will be compared to placebo to determine efficacy and safety of treatment in
        patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or
        preserved left ventricular ejection fraction.
  This is an international, randomized, double-blind, placebo-controlled, event-driven trial of
        finerenone for the treatment hospitalized heart failure patients with mildly reduced or
        preserved ejection fraction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Composite total of HF events and cardiovascular (CV) death.
  time frame: Ongoing, up to ~30 months
  description: Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
  measure: Number of serious adverse events.
  time frame: Ongoing, up to ~30 months
  description: Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
  measure: Number of adverse events leading to discontinuation of study drug.
  time frame: Ongoing, up to ~30 months
  description: Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
  measure: Time to first occurrence of the composite of CV death or HF event.
  time frame: Ongoing, up to ~30 months
  description: Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
  measure: Total HF events.
  time frame: Ongoing, up to ~30 months
  description: Total HF events with finerenone compared to placebo.
  measure: Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
  time frame: 6 Months
  measure: Time to CV death.
  time frame: Ongoing, up to ~30 months
  description: Time to CV death with finerenone compared to placebo.
  measure: Time to death from any cause.
  time frame: Ongoing, up to ~30 months
  description: Time to death from any cause with finerenone compared to placebo.
  measure: Total hospitalizations for any cause.
  time frame: Ongoing, up to ~30 months
  description: Total hospitalizations for any cause with finerenone compared to placebo.
  measure: Total number of days alive and out of the hospital.
  time frame: Ongoing, up to ~30 months
  description: Days alive and out of hospital with finerenone compared to placebo.
  measure: Number of patients with sustained decrease in eGFR ≥40% relative to baseline.
  time frame: Ongoing, up to ~30 months
  description: Sustained decrease in eGFR ≥40% relative to baseline with finerenone compared to placebo.
  measure: Number of patients with sustained eGFR <15 ml/min/1.73 m^2.
  time frame: Ongoing, up to ~30 months
  description: Sustained eGFR <15 ml/min/1.73 m^2 with finerenone compared to placebo.
  measure: Number of patients requiring initiation of dialysis or renal transplant.
  time frame: Ongoing, up to ~30 months
  description: Initiation of dialysis or renal transplant with finerenone compared to placebo.
  arm group label: Finerenone
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Finerenone
  description: Oral finerenone
  arm group label: Finerenone
  other name: Kerendia
  intervention type: Drug
  intervention name: Placebo
  description: Matching oral placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc Bonaca
  phone: 303-860-9900
  email: info@cpcmed.org
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No
  ipd description: No current plan to share individual patient data with other researchers.