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

What this study is about

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• Treatment with non-steroidal MRA (nsMRA)
• Documented prior history of severe hyperkalemia in the setting of MRA use
• eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L
• 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
• Known hypersensitivity to the IP (active substance or excipients)
• Any other condition or therapy which would make the participant unsuitable for the study
• Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Where this trial is running

• FIN-10004 Fairhope, AL Investigational Site, Fairhope, Alabama, United States
• FIN-10075 San Diego, CA Investigational Site, San Diego, California, United States
• FIN-10002 Kansas City, MO Investigational Site, Kansas City, Missouri, United States
• FIN-10015 Austin, TX Investigational Site, Austin, Texas, United States
• FIN-21003 Goiania, Goias Investigational Site, Goiânia, Goiás, Brazil
• FIN-21049 Sao Paulo, Investigational Site, Sao Paulp, Sap Paulo, Brazil
• FIN-21004 Braganca Paulista, Investigational Site, Bragança Paulista, São Paulo, Brazil
• FIN-11012 Surrey, BC Investigational Site, Surrey, British Columbia, Canada

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06033950.