Recruiting NCT06008197

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

Phase III Interventional Heart Failure Acute Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Finerenone, Placebo.
Who it may be relevant to: Registry conditions: Heart Failure, Acute Heart Failure. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +17
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Detailed description

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

Interventions

Drug Finerenone
Oral finerenone
Drug Placebo
Matching oral placebo

Primary outcome measures

Composite of total HF events and cardiovascular (CV) death. [Time frame: Ongoing, up to ~30 months]
Number of serious adverse events. [Time frame: Ongoing, up to ~30 months]
Number of adverse events leading to discontinuation of study drug. [Time frame: Ongoing, up to ~30 months]

Secondary outcome measures (5)

Time to first occurrence of the composite of CV death or HF event. [Time frame: Ongoing, up to ~30 months]
Total HF events. [Time frame: Ongoing, up to ~30 months]
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6. [Time frame: 6 Months]
Time to CV death. [Time frame: Ongoing, up to ~30 months]
Time to death from any cause. [Time frame: Ongoing, up to ~30 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment