Last updated: February 29, 2024
Sponsor: Colorado Prevention Center
Overall Status: Active - Recruiting
Phase
3
Condition
Congestive Heart Failure
Chest Pain
Heart Failure
Treatment
Placebo
Finerenone
Clinical Study ID
NCT06008197
202301CPC
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provide electronic or written informed consent, either personally or through a legallyauthorized representative
- Age ≥18 years
- Current hospitalization or recently discharged with the primary diagnosis of heartfailure
- Heart failure signs and symptoms at the time of hospital admission
- Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
- Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-typenatriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); orelevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF
Exclusion
Exclusion Criteria:
- Treatment with a mineralocorticoid receptor antagonist (MRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or serum/plasmapotassium >5.0 mmol/L at screening
- Acute myocardial infarction, coronary revascularization, valve replacement/repair, orimplantation of a cardiac resynchronization therapy device within 30 days
- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
- Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases,accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes,known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, orknown pericardial constriction
- Probable alternative cause of participant's heart failure symptoms
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
Study Design
Total Participants: 5200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 17, 2024
Estimated Completion Date:
April 30, 2026
Study Description
Connect with a study center
Aurora, CO Investigative Site
Aurora, Colorado 80045
United StatesSite Not Available
Denver, CO Investigative Site
Denver, Colorado 80204
United StatesSite Not Available
Boca Raton, FL Investigative Site
Boca Raton, Florida 33434
United StatesActive - Recruiting
Kansas City, MO Investigative Site
Kansas City, Missouri 64111
United StatesActive - Recruiting
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