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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT06033950

Run by

Colorado Prevention Center

People needed

2600

Starts

2024-08-20

Expected to finish

2028-01-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Phoenix, AZ Investigative Site FIN-10115 — Phoenix, Arizona, United States (enrolling)
• FIN-10401, Yuma, AZ — Yuma, Arizona, United States (enrolling)
• Chula Vista, CA Investigative Site FIN-10419 — Chula Vista, California, United States (enrolling)
• Chula Vista, CA Investigative Site FIN-10111 — Chula Vista, California, United States (enrolling)
• FIN-10407, Northridge, CA — Northridge, California, United States (enrolling)
• FIN-10412, Orange, CA — Orange, California, United States (enrolling)
• FIN-10070, Pamona, CA — Pomona, California, United States (enrolling)
• FIN-10024, Sacramento, CA — Sacramento, California, United States (enrolling)
• FIN-10406, San Diego, CA — San Diego, California, United States (enrolling)
• San Diego, CA Investigative Site FIN-10420 — San Diego, California, United States (enrolling)
• FIN-10075 San Diego, CA Investigational Site — San Diego, California, United States (enrolling)
• San Francisco, CA Investigative Site FIN-10023 — San Francisco, California, United States (enrolling)
• FIN-10423, Sherman Oaks, CA — Sherman Oaks, California, United States (enrolling)
• FON-10409, Tarzana, CA — Tarzana, California, United States (enrolling)
• FIN-10109, Van Nuys, CA — Van Nuys, California, United States (enrolling)
• FIN-10408, West Covina, CA — West Covina, California, United States (enrolling)
• FIN-10013, West Hills, CA — West Hills, California, United States (enrolling)
• FIN-10110, Aurora, CO — Aurora, Colorado, United States (enrolling)
• FIN-10001, Aurora, CO — Aurora, Colorado, United States (enrolling)
• Bradenton, FL Investigative Site FIN-10125 — Bradenton, Florida, United States (enrolling)
• FIN-10104, Hialeah, FL — Hialeah, Florida, United States (enrolling)
• FIN-10028, Jacksonville, FL — Jacksonville, Florida, United States (enrolling)
• FIN-10105, Miami, FL — Miami, Florida, United States (enrolling)
• FIN-10113, Miramar, FL — Miramar, Florida, United States (enrolling)
• FIN-10004 Fairhope, AL Investigational Site — Fairhope, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.