Clinical trial NCT06033950: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Keywords: Reduced ejection fraction
Symptomatic heart failure
Lead sponsor: Colorado Prevention Center
Sponsor class: OTHER
Collaborators: name: St. Luke's Hospital, Kansas City, Missouri
name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2023-09-13
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to first occurrence of cardiovascular (CV) death or HF event.
timeFrame: Ongoing, up to ~30 months
measure: Number of serious adverse events
timeFrame: Ongoing, up to ~30 months
measure: Number of adverse events leading to discontinuation of study drug.
timeFrame: Ongoing, up to ~30 months
Secondary outcomes:
measure: Timing and occurrence of total CV deaths and HF events
timeFrame: Ongoing, up to ~30 months
measure: Timing and occurrence of total HF events
timeFrame: Ongoing, up to ~30 months
measure: Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
timeFrame: 180 days
measure: Time to CV death.
timeFrame: Ongoing, up to ~30 months
measure: Time to all-cause death.
timeFrame: Ongoing, up to ~30 months
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: FIN-10004 Fairhope, AL Investigational Site
state: Alabama
city: San Diego
country: United States
facility: FIN-10075 San Diego, CA Investigational Site
state: California
city: Kansas City
country: United States
facility: FIN-10002 Kansas City, MO Investigational Site
state: Missouri
city: Austin
country: United States
facility: FIN-10015 Austin, TX Investigational Site
state: Texas
city: Goiania
country: Brazil
facility: FIN-21003 Goiania, Goias Investigational Site
state: Goias
city: Braganca Paulista
country: Brazil
facility: FIN-21004 Braganca Paulista, Investigational Site
state: Sao Paulo
city: Sao Paulp
country: Brazil
facility: FIN-21049 Sao Paulo, Investigational Site
state: Sap Paulo
city: Surrey
country: Canada
facility: FIN-11012 Surrey, BC Investigational Site
state: British Columbia
Study officials:
References: