A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Reduced ejection fraction, Symptomatic heart failure
Eligibility Criteria
Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years or legal age of majority Symptomatic HFrEF per protocol defined criteria Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: Treatment with non-steroidal MRA (nsMRA) eGFR < 25 mL/min/1.73m² and / or serum/plasma potassium > 5.0 mmol/L Type 1 acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned Prior or planned heart transplant Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure Symptomatic bradycardia or second- or third-degree heart block without a pacemaker Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction Probable alternative cause of participant's HF Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers Any other condition or therapy which would make the participant unsuitable for the study Concurrent participation in another interventional clinical study using an investigational agent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Finerenone
Placebo