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A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF)

Primary Purpose

Heart Failure, Acute Heart Failure

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finerenone
Placebo
Sponsored by
Colorado Prevention Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Preserved ejection fraction, Mildly reduced ejection fraction, Hospitalized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years Current hospitalization or recently discharged with the primary diagnosis of heart failure Heart failure signs and symptoms at the time of hospital admission Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher) Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF Exclusion Criteria: Treatment with a mineralocorticoid receptor antagonist (MRA) Documented prior history of severe hyperkalemia in the setting of MRA use Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or serum/plasma potassium >5.0 mmol/L at screening Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days Hemodynamically significant (severe) uncorrected primary cardiac valvular disease Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction Probable alternative cause of participant's heart failure symptoms Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Finerenone

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Composite total of HF events and cardiovascular (CV) death.
    Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
    Number of serious adverse events.
    Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
    Number of adverse events leading to discontinuation of study drug.
    Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.

    Secondary Outcome Measures

    Time to first occurrence of the composite of CV death or HF event.
    Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
    Total HF events.
    Total HF events with finerenone compared to placebo.
    Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
    Time to CV death.
    Time to CV death with finerenone compared to placebo.
    Time to death from any cause.
    Time to death from any cause with finerenone compared to placebo.

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Colorado Prevention Center
    Collaborators
    Saint Luke's Hospital of Kansas City, Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008197
    Brief Title
    A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
    Acronym
    REDEFINE-HF
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Colorado Prevention Center
    Collaborators
    Saint Luke's Hospital of Kansas City, Bayer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Acute Heart Failure
    Keywords
    Heart failure, Preserved ejection fraction, Mildly reduced ejection fraction, Hospitalized

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    5200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Finerenone
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Finerenone
    Other Intervention Name(s)
    Kerendia
    Intervention Description
    Oral finerenone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching oral placebo
    Primary Outcome Measure Information:
    Title
    Composite total of HF events and cardiovascular (CV) death.
    Description
    Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of serious adverse events.
    Description
    Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of adverse events leading to discontinuation of study drug.
    Description
    Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Secondary Outcome Measure Information:
    Title
    Time to first occurrence of the composite of CV death or HF event.
    Description
    Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Total HF events.
    Description
    Total HF events with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
    Time Frame
    6 Months
    Title
    Time to CV death.
    Description
    Time to CV death with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Time to death from any cause.
    Description
    Time to death from any cause with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Other Pre-specified Outcome Measures:
    Title
    Total hospitalizations for any cause.
    Description
    Total hospitalizations for any cause with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Total number of days alive and out of the hospital.
    Description
    Days alive and out of hospital with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of patients with sustained decrease in eGFR ≥40% relative to baseline.
    Description
    Sustained decrease in eGFR ≥40% relative to baseline with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of patients with sustained eGFR <15 ml/min/1.73 m^2.
    Description
    Sustained eGFR <15 ml/min/1.73 m^2 with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of patients requiring initiation of dialysis or renal transplant.
    Description
    Initiation of dialysis or renal transplant with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years Current hospitalization or recently discharged with the primary diagnosis of heart failure Heart failure signs and symptoms at the time of hospital admission Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher) Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF Exclusion Criteria: Treatment with a mineralocorticoid receptor antagonist (MRA) Documented prior history of severe hyperkalemia in the setting of MRA use Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or serum/plasma potassium >5.0 mmol/L at screening Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days Hemodynamically significant (severe) uncorrected primary cardiac valvular disease Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction Probable alternative cause of participant's heart failure symptoms Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc Bonaca
    Phone
    303-860-9900
    Email
    info@cpcmed.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No current plan to share individual patient data with other researchers.

    Learn more about this trial

    A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

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