Tests finerenone in people hospitalized with heart failure and preserved heart pumping
Compares finerenone with placebo in adults hospitalized for acute decompensated heart failure.
Plain-language title generated from the registry record
Registry title: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Key facts
- Where
- Brasov, Bucharest, Piteşti, and Timișoara, RomaniaSee the 4 sites
- Phase
- Phase 3
Where in Romania
- BrasovBrasov, RomaniaTaking people
- BucharestBucharest, RomaniaTaking people
- PiteştiPiteşti, RomaniaTaking people
- TimișoaraTimișoara, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Colorado Prevention Center
- Trial code
- NCT06008197
- Record updated
- 10 September 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: 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 without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF.
Exclusion: Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA); Documented prior history of severe hyperkalemia in the setting of MRA use; Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers; Acute myocardial infarction due to plaque rupture, 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; Known hypersensitivity to the IP (active substance or excipients); Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening.