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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
NCT06033950 · Colorado Prevention Center
In plain English
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Official title
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)
About this study
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Eligibility 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
Study design
Enrollment target: 2600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-08-20
Estimated completion: 2028-04
Last updated: 2025-03-11
Interventions
Drug: FinerenoneDrug: Placebo
Primary outcomes
- • Time to first occurrence of cardiovascular (CV) death or HF event. (Ongoing, up to ~30 months)
- • Number of serious adverse events (Ongoing, up to ~30 months)
- • Number of adverse events leading to discontinuation of study drug. (Ongoing, up to ~30 months)
Sponsor
Colorado Prevention Center · other
With: St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Contacts & investigators
ContactMarc Bonaca · contact · info@cpcmed.org · (303) 860-9900
All locations (8)
FIN-10004 Fairhope, AL Investigational SiteRecruiting
Fairhope, Alabama, United States
FIN-10075 San Diego, CA Investigational SiteRecruiting
San Diego, California, United States
FIN-10002 Kansas City, MO Investigational SiteRecruiting
Kansas City, Missouri, United States
FIN-10015 Austin, TX Investigational SiteRecruiting
Austin, Texas, United States
FIN-21003 Goiania, Goias Investigational SiteRecruiting
Goiânia, Goiás, Brazil
FIN-21049 Sao Paulo, Investigational SiteRecruiting
Sao Paulp, Sap Paulo, Brazil
FIN-21004 Braganca Paulista, Investigational SiteRecruiting
Bragança Paulista, São Paulo, Brazil
FIN-11012 Surrey, BC Investigational SiteRecruiting
Surrey, British Columbia, Canada