Actively Recruiting
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
Led by Colorado Prevention Center · Updated on 2025-03-11
2600
Participants Needed
8
Research Sites
188 weeks
Total Duration
On this page
Sponsors
C
Colorado Prevention Center
Lead Sponsor
S
St. Luke's Hospital, Kansas City, Missouri
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide electronic or written informed consent, either personally or through a legally authorized representative
- Age 18 years or older or legal age of majority in participant's country
- Symptomatic heart failure with reduced ejection fraction per protocol criteria
- Not receiving steroidal mineralocorticoid receptor antagonists due to intolerance, contraindication, or ineligibility
- Negative pregnancy test and agreement to use contraception during trial (female participants only)
You will not qualify if you...
- Treatment with non-steroidal mineralocorticoid receptor antagonists
- History of severe hyperkalemia related to mineralocorticoid receptor antagonist use
- Estimated glomerular filtration rate below 25 mL/min/1.73m² or potassium above 5.0 mmol/L
- Acute myocardial infarction, coronary revascularization, valve replacement/repair, or cardiac resynchronization therapy device implantation within 30 days or planned
- Prior or planned heart transplant
- Severe uncorrected primary cardiac valvular disease causing heart failure
- Symptomatic bradycardia or second/third-degree heart block without a pacemaker
- Cardiomyopathy caused by acute inflammatory heart disease, infiltrative or accumulation diseases, muscular dystrophies, reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
- Alternative probable cause of heart failure
- Use of potent cytochrome P450 3A4 inhibitors or moderate/strong CYP3A4 inducers
- Known hypersensitivity to the investigational drug or its ingredients
- Any condition or therapy making participation unsuitable
- Participation in another interventional clinical trial with investigational agents within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
FIN-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, United States, 36532
Actively Recruiting
2
FIN-10075 San Diego, CA Investigational Site
San Diego, California, United States, 92243
Actively Recruiting
3
FIN-10002 Kansas City, MO Investigational Site
Kansas City, Missouri, United States, 64111
Actively Recruiting
4
FIN-10015 Austin, TX Investigational Site
Austin, Texas, United States, 78705
Actively Recruiting
5
FIN-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, Brazil, 74453-200
Actively Recruiting
6
FIN-21049 Sao Paulo, Investigational Site
Sao Paulp, Sap Paulo, Brazil, 05652-900
Actively Recruiting
7
FIN-21004 Braganca Paulista, Investigational Site
Bragança Paulista, São Paulo, Brazil, 12916542
Actively Recruiting
8
FIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, Canada, V3V OC6
Actively Recruiting
Research Team
M
Marc Bonaca
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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