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)
Colorado Prevention Center
Summary
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).
Description
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugFinerenone
Oral finerenone.
- DrugPlacebo
Matching oral placebo.
Locations (8)
- FIN-10004 Fairhope, AL Investigational SiteFairhope, Alabama
- FIN-10075 San Diego, CA Investigational SiteSan Diego, California
- FIN-10002 Kansas City, MO Investigational SiteKansas City, Missouri
- FIN-10015 Austin, TX Investigational SiteAustin, Texas
- FIN-21003 Goiania, Goias Investigational SiteGoiânia, Goiás
- FIN-21049 Sao Paulo, Investigational SiteSao Paulp, Sap Paulo