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

Prior treatment

• Treatment with non-steroidal MRA (nsMRA)
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Prior or planned heart transplant
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
• Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Other illness

• Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
• 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
• Known hypersensitivity to the IP (active substance or excipients)
• Any other condition or therapy which would make the participant unsuitable for the study

Lab values

• eGFR \< 25 mL/min/1.73m² and / or potassium \> 5.0 mmol/L

Other

• Probable alternative cause of participant's HF

• Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
• Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
• 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)