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Evaluating Finerenone for 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)

Phase 3 Interventional Colorado Prevention Center · NCT06008197

This study is testing if a medication called finerenone can help hospitalized patients with heart failure feel better and live longer compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5200 (estimated)
Ages18 Years and up
SexAll
SponsorColorado Prevention Center Academic / other
Locations299 sites (Birmingham, Alabama and 298 other locations)
Trial IDNCT06008197 on ClinicalTrials.gov

What this trial studies

This international, randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of finerenone in hospitalized patients with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. Participants will receive either finerenone or a placebo while being monitored for morbidity and mortality outcomes. The study focuses on patients with specific heart failure symptoms and elevated biomarkers, ensuring a targeted approach to treatment. The trial is designed to provide robust data on the potential benefits of finerenone in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are currently hospitalized or recently discharged with a primary diagnosis of heart failure and specific ejection fraction criteria.

Not a fit: Patients with severe hyperkalemia or those currently on mineralocorticoid receptor antagonists may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for hospitalized heart failure patients.

How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific application of finerenone is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

Exclusion Criteria:

* 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)

Where this trial is running

Birmingham, Alabama and 298 other locations

+249 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureAcute Heart FailureHeart failurePreserved ejection fractionMildly reduced ejection fractionHospitalized
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.