RecruitingHeart Failure
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
Sponsor: Colorado Prevention Center
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
- ✓ Current hospitalization or recently discharged with the primary diagnosis of heart failure
- ✓ Heart failure signs and symptoms at the time of hospital admission
- ✓ Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
- ✓ Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
- ✓ Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
- ✓ Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)
You may not qualify if…
- ✕ Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
- ✕ Documented prior history of severe hyperkalemia in the setting of MRA use
- ✕ Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
- ✕ Estimated glomerular filtration rate (eGFR) \<30 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
- ✕ Prior or planned heart transplant
- ✕ Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
- ✕ Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
Where it's recruiting
Source: ClinicalTrials.gov · NCT06024746 · last updated 2025-03-11