RecruitingPhase 3NCT06008197
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
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)
Sponsor
Colorado Prevention Center
Enrollment
5,200 participants
Start Date
Jan 17, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria9
- Current or planned long-term 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 potassium \>5.0 mmol/L at screening
- 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
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
- Known hypersensitivity to the IP (active substance or excipients)
Interventions
DRUGFinerenone
Oral finerenone
DRUGPlacebo
Matching oral placebo
Locations(80)
View Full Details on ClinicalTrials.gov
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NCT06008197
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