A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Conditions

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Heart Failure Acute Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Finerenone

Group Type EXPERIMENTAL

Finerenone

Intervention Type DRUG

Oral finerenone

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching oral placebo

Interventions

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Finerenone

Oral finerenone

Intervention Type DRUG

Placebo

Matching oral placebo

Intervention Type DRUG

Other Intervention Names

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Kerendia

Eligibility Criteria

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Inclusion Criteria

* Provide electronic or written informed consent, either personally or through a legally authorized representative
* Age ≥18 years
* Current hospitalization or recently discharged 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF

Exclusion Criteria

* 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 serum/plasma potassium \>5.0 mmol/L at screening
* Acute myocardial infarction, 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No