Evaluating Finerenone for Heart Failure Patients Who Can't Use Standard Treatments
A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)
This study is testing if finerenone can help adults with heart failure who can't take standard treatments feel better and stay safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Colorado Prevention Center Academic / other |
| Locations | 8 sites (Fairhope, Alabama and 7 other locations) |
| Trial ID | NCT06033950 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic heart failure and reduced ejection fraction who are not on steroidal mineralocorticoid receptor antagonists due to intolerance or contraindications.
Not a fit: Patients currently receiving non-steroidal mineralocorticoid receptor antagonists or those with severe renal impairment or recent significant cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for heart failure patients who cannot tolerate standard medications.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel treatment pathway.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fairhope, Alabama and 7 other locations
- FIN-10004 Fairhope, AL Investigational Site — Fairhope, Alabama, United States (Recruiting)
- FIN-10075 San Diego, CA Investigational Site — San Diego, California, United States (Recruiting)
- FIN-10002 Kansas City, MO Investigational Site — Kansas City, Missouri, United States (Recruiting)
- FIN-10015 Austin, TX Investigational Site — Austin, Texas, United States (Recruiting)
- FIN-21003 Goiania, Goias Investigational Site — Goiânia, Goiás, Brazil (Recruiting)
- FIN-21049 Sao Paulo, Investigational Site — Sao Paulp, Sap Paulo, Brazil (Recruiting)
- FIN-21004 Braganca Paulista, Investigational Site — Bragança Paulista, São Paulo, Brazil (Recruiting)
- FIN-11012 Surrey, BC Investigational Site — Surrey, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Marc Bonaca
- Email: info@cpcmed.org
- Phone: (303) 860-9900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.