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)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06008197Tipo: INTERVENTIONALInicio: 17 de ene de 2024Fin estimado: 1 de dic de 2027

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)
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
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

Criterios de exclusión

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)

Intervenciones

drug

Finerenone

Oral finerenone

drug

Placebo

Matching oral placebo

Ubicaciones

Córdoba, Córdoba Investigative Site 20014

Córdoba, Córdoba Province, Argentina

Marc Bonaca · info@cpcmed.org · 303-860-9900

RECRUITING

Patrocinadores

PrincipalColorado Prevention Center

ColaboradorSt. Luke's Hospital, Kansas City, Missouri

ColaboradorBayer

Contactos

Marc Bonaca

CONTACT

info@cpcmed.org 303-860-9900

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