NCT06033950RecruitingPhase 3
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 Center184 sites in 3 countries2,600 target enrollmentStarted: August 20, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Colorado Prevention Center
- Enrollment
- 2,600
- Locations
- 184
- Primary Endpoint
- Number of serious adverse events
Study Overview
Brief 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).
Detailed Description
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Finerenone
Experimental
Intervention: Finerenone (Drug)
Outcomes
Primary Outcomes
Number of serious adverse events
Time Frame: Ongoing, up to ~30 months
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Time to first occurrence of cardiovascular (CV) death or HF event.
Time Frame: Ongoing, up to ~30 months
\- Time to first CV death or HF event with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
Time Frame: Ongoing, up to ~30 months
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Secondary Outcomes
- Timing and occurrence of total CV deaths and HF events(Ongoing, up to ~30 months)
- Timing and occurrence of total HF events(Ongoing, up to ~30 months)
- Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.(180 days)
- Time to CV death.(Ongoing, up to ~30 months)
- Time to all-cause death.(Ongoing, up to ~30 months)
Investigators
Study Sites (184)
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