Evaluating Finerenone for Heart Failure Patients Who Can't Use Standard Treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of finerenone in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible for steroidal mineralocorticoid receptor antagonists (sMRA). Participants will receive either finerenone or a placebo to determine the drug's impact on their condition. The study will include adults aged 18 and older who meet specific symptomatic criteria for HFrEF and have a history of intolerance to sMRA. The trial will monitor clinical outcomes and safety profiles over the study duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• FIN-10004 Fairhope, AL Investigational Site
  Fairhope, Alabama, United States Recruiting
• Phoenix, AZ Investigative Site FIN-10115
  Phoenix, Arizona, United States Recruiting
• FIN-10401, Yuma, AZ
  Yuma, Arizona, United States Recruiting
• Chula Vista, CA Investigative Site FIN-10419
  Chula Vista, California, United States Recruiting
• Chula Vista, CA Investigative Site FIN-10111
  Chula Vista, California, United States Recruiting
• FIN-10407, Northridge, CA
  Northridge, California, United States Recruiting

+126 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Marc Bonaca
• Email: info@cpcmed.org
• Phone: (303) 860-9900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.