Last updated 10 days ago
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
1500 patients around the world
Available in Brazil, United States
This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).
Colorado Prevention Center
1500Patients around the world
This study is for people with
Heart failure
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.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.Known hypersensitivity to the IP active substance or excipients.Any other condition or therapy which would make the patient unsuitable for this study.
StudyCONFIRMATION
SponsorColorado Prevention Center
Study typeInterventional
Conditions
Heart failure
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06024746
