CONFIRMATION-HF
The CONFIRMATION-HF study investigates the efficacy and safety of combination therapy including finerenone and empagliflozin in patients hospitalized with heart failure.
About This Study
Summary
Currently, 1 in 5 people is at risk of developing heart failure (HF) at some point in their lifetime. Effectively managing the symptoms of chronic HF—including shortness of breath, fatigue, and fluid retention—can decrease the burden of this disease and enhance patients’ quality of life. The medication empagliflozin helps the body get rid of excess fluid. This lowers blood pressure, decreases how hard the heart has to work, and reduces the risk of heart-associated complications and hospitalizations. Finerenone targets the heart and kidneys, reducing inflammation and fibrosis, which are key factors in heart failure progression and other cardiovascular complications.
In CONFIRMATION-HF, researchers hope to learn that adding both finerenone and empagliflozin to current standard-care treatment will further reduce symptoms and complications in patients hospitalized with heart failure. Participants who are cleared to join CONFIRMATION-HF are assigned randomly (50:50, like a coin toss) to receive either the standard care medications assigned to them or standard care plus finerenone and empagliflozin. Participants can anticipate being contacted by research team members and involved in CONFIRMATION-HF for up to 6 months after hospitalization.
To be included in CONIRMATION-HF, participants must be / have
- Adult (18 years or older)
- Currently hospitalized 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) for patients in sinus rhythm OR NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured at or within 72 hours before hospital admission
- Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide)
To be included in CONIRMATION-HF, participants must not be / have
- Type 1 diabetes or prior history of diabetic ketoacidosis
- Prior history of severe hyperkalemia in the setting of non-steroidal mineralocorticoid receptor antagonist use
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² 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
Keywords
Empagliflozin; Finerenone; Heart disease; Heart failure; Hospitalization
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Valerie Renard, NP, PhDc, is a hospitalist and research scientist in Carilion’s Department of Medicine Clinical Research Unit. She's keenly interested in learning how nonmedical health factors—for example, socioeconomic status, neighborhood, and access to transportation—influence patient outcomes. The questions she asks in her research reflect her belief that everyone—regardless of their zip code or educational level—deserves optimal opportunities for wellness.
Official title of study
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
Funding mechanism
Industry sponsored by Colorado Prevention Clinic