RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Aurora

Aurora, CO Investigative Site, Aurora, Colorado, United States, 80045

Denver

Denver, CO Investigative Site, Denver, Colorado, United States, 80204

Boca Raton

Boca Raton, FL Investigative Site, Boca Raton, Florida, United States, 33434

Kansas City

Kansas City, MO Investigative Site, Kansas City, Missouri, United States, 64111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Colorado Prevention Center,

Study Record Dates

2026-04