A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
5200 patients around the world
Available in United States, Argentina
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.
Colorado Prevention Center
1Research sites
5200Patients around the world
This study is for people with
Heart failure
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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.
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.
Sites
Instituto de Investigaciones Clínicas (IIC) - Rosario
Paraguay 160, S2000CVD Rosario, Santa Fe, Argentina