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)
Colorado Prevention Center
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.
Description
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provide written informed consent * Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * Current hospitalization or recently discharged (during or within 30 days of discharge) 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) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients with…
Interventions
- DrugFinerenone
Oral finerenone
- DrugPlacebo
Matching oral placebo
Locations (299)
- Birmingham, AL Investigative Site 10012Birmingham, Alabama
- Fairhope, AL Investigative Site 10004Fairhope, Alabama
- Huntsville, AL Investigative Site 10026Huntsville, Alabama
- Glendale, AZ Investigative Site 10096Glendale, Arizona
- Scottsdale, AZ Investigative Site 10003Scottsdale, Arizona
- Chula Vista, CA Investigative Site 10111Chula Vista, California