RecruitingPhase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares finerenone with a placebo, a treatment with no active drug, to see how safe it is and whether it reduces illness and death. It is for adults in the hospital or recently sent home after worsening heart failure whose heart pumping strength is mildly reduced or preserved.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study.
  • Be at least 18, or the legal adult age in your country if it is higher.
  • Be in the hospital mainly for heart failure, or have left the hospital within the past 30 days.
  • Have had signs and symptoms of heart failure when admitted to the hospital.
  • Have a heart scan showing an ejection fraction of at least 40%. This is the share of blood the heart's main pumping chamber pushes out with each beat.
  • Have high blood levels of markers linked to heart failure: NTproBNP at least 500 pg/mL or BNP at least 125 pg/mL. If you have atrial fibrillation, an irregular heartbeat, the levels must be at least 1500 or 375 pg/mL, respectively.

Who can't join

  • Take, or plan to take long term, an MRA, a drug that blocks the hormone aldosterone; or have had severely high blood potassium while taking one.
  • Have an eGFR below 25, a test result showing very low kidney function, or blood potassium above 5.0 mmol/L at screening.
  • Within the past 30 days, have had a heart attack caused by plaque breaking open in an artery, a procedure to restore heart blood flow, heart valve repair or replacement, or a device placed to help the heart's chambers beat together.
  • Have severe, untreated heart valve disease that affects blood flow.
  • Have certain heart muscle diseases caused by sudden inflammation, substances building up in the heart, muscular dystrophy, or a cause that can be reversed. Other excluded conditions include thick heart muscle that blocks blood flow, complex heart defects present at birth, or a stiff sac around the heart.
  • Have another likely cause for your heart failure symptoms.
  • Take certain medicines that strongly block or moderately or strongly boost CYP3A4, a protein that helps the body break down drugs.
  • Have a known allergy to the study drug or any of its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (82)

AL

AZ

CA

CO

FL

GA

ID

IL

IN

KS

KY

LA

MA

MD

MN

MO

MS

NC

NE

NJ

NY

OH

OK

PA

RI

SC

TN

TX

VA

VT

WA

WI