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

Heart Failure Clinical Trial

— FINALITY-HF  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033950
• Other study ID #: 202304CPC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: Colorado Prevention Center
• Contact: Marc Bonaca
• Phone: (303) 860-9900
• Email: info[@]cpcmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonist (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2600
• Est. completion date: January 2028
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide electronic or written informed consent, either personally or through a legally authorized representative
• Age =18 years or legal age of majority
• 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)
• eGFR < 25 mL/min/1.73m² and / or serum/plasma potassium > 5.0 mmol/L
• Type 1 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
• Any other condition or therapy which would make the participant unsuitable for the study
• Concurrent participation in another interventional clinical study using an investigational agent

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Finerenone
Oral finerenone.
• Placebo
Matching oral placebo.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Colorado Prevention Center	Bayer, Saint Luke's Hospital of Kansas City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of cardiovascular (CV) death or HF event.	- Time to first CV death or HF event with finerenone compared to placebo.	Ongoing, up to ~30 months
Primary	Number of serious adverse events	- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.	Ongoing, up to ~30 months
Primary	Number of adverse events leading to discontinuation of study drug.	- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Timing and occurrence of total HF events and CV deaths.	- Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180.	- Change in KCCQ-TSS with finerenone compared to placebo.	180 days
Secondary	Time to first occurrence of composite kidney endpoint.	Composite endpoint: Estimated glomerular filtration rate (eGFR) =50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Time to CV death.	- Time to CV death with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Time to death from any cause.	- Time to all-cause mortality with finerenone compared to placebo.	Ongoing, up to ~30 months