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 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 202304CPC
• Study Type: interventional
• Target: 2,600
• Locations: 3 countries
• Sites: 8

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).

Conditions

Heart Failure

Keywords

Reduced ejection fraction; Symptomatic heart failure

Outcome Measures

Primary Outcomes (3)

• 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

• Number of serious adverse events

  \- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.

  Ongoing, up to ~30 months

• 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 Outcomes (5)

• 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

Study Arms (2)

Finerenone

EXPERIMENTAL

Drug: Finerenone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Finerenone DRUG

Oral finerenone.

Finerenone

Placebo DRUG

Matching oral placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado Prevention Center: lead
• St. Luke's Hospital, Kansas City, Missouri: collaborator
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (8)

FIN-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, 36532, United States

RECRUITING

FIN-10075 San Diego, CA Investigational Site

San Diego, California, 92243, United States

RECRUITING

FIN-10002 Kansas City, MO Investigational Site

Kansas City, Missouri, 64111, United States

RECRUITING

FIN-10015 Austin, TX Investigational Site

Austin, Texas, 78705, United States

RECRUITING

FIN-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, 74453-200, Brazil

RECRUITING

FIN-21049 Sao Paulo, Investigational Site

Sao Paulp, Sap Paulo, 05652-900, Brazil

RECRUITING

FIN-21004 Braganca Paulista, Investigational Site

Bragança Paulista, São Paulo, 12916542, Brazil

RECRUITING

FIN-11012 Surrey, BC Investigational Site

Surrey, British Columbia, V3V OC6, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marc Bonaca

CONTACT

(303) 860-9900; info@cpcmed.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: August 20, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (4); BR (3); CA (1)