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

Colorado Prevention Center Clinical Research

Status and phase

Enrolling

Phase 3

Conditions

Acute Heart Failure

Heart Failure

Treatments

Drug: Finerenone

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06008197

202301CPC

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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