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
NCT ID: NCT06033950
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2600 participants
INTERVENTIONAL
2024-08-20
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Finerenone
Finerenone
Oral finerenone.
Placebo
Placebo
Matching oral placebo.
Interventions
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Finerenone
Oral finerenone.
Placebo
Matching oral placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Luke's Hospital, Kansas City, Missouri
OTHER
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
INDUSTRY
Colorado Prevention Center
OTHER
Responsible Party
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Locations
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FIN-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, United States
FIN-10075 San Diego, CA Investigational Site
San Diego, California, United States
FIN-10002 Kansas City, MO Investigational Site
Kansas City, Missouri, United States
FIN-10015 Austin, TX Investigational Site
Austin, Texas, United States
FIN-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, Brazil
FIN-21049 Sao Paulo, Investigational Site
Sao Paulp, Sap Paulo, Brazil
FIN-21004 Braganca Paulista, Investigational Site
Bragança Paulista, São Paulo, Brazil
FIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Marc Bonaca, MD
Role: primary
Marc Bonaca
Role: primary
Other Identifiers
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202304CPC
Identifier Type: -
Identifier Source: org_study_id
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