Clinical trial NCT06024746: A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
Official title: Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Keywords: Heart Failure
Hospitalized
Lead sponsor: Colorado Prevention Center
Sponsor class: OTHER
Collaborators: name: Saint Luke's Mid America Heart Institute
name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2023-09-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical benefit
timeFrame: 6 months
measure: Number of serious adverse events (AEs).
timeFrame: 6 months
measure: Number of adverse events leading to discontinuation of study drug.
timeFrame: 6 months
Secondary outcomes:
measure: Time to first death from any cause or HF event.
timeFrame: 6 months
measure: Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
timeFrame: 6 months
measure: Number of HF events from baseline to Day 90.
timeFrame: 90 days
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: CON-10004 Fairhope, AL Investigational Site
state: Alabama
city: El Centro
country: United States
facility: CON-10075 El Centro, CA Investigational Site
state: California
city: Sacramento
country: United States
facility: CON-10024 Sacramento, CA Investigational Site
state: California
city: Atlanta
country: United States
facility: CON-10022 Atlanta, GA Investigational Site
state: Georgia
city: Baton Rouge
country: United States
facility: CON-10030 Baton Rouge, LA Investigational Site
state: Louisiana
city: Kansas City
country: United States
facility: CON-10002 Kansas City, MO Investigative Site
state: Missouri
city: Amarillo
country: United States
facility: CON-10045 Amarillo, TX Investigational Site
state: Texas
city: Austin
country: United States
facility: CON-10015 Austin, TX Investigational Site
state: Texas
city: Goiania
country: Brazil
facility: CON-21003 Goiania, Goias Investigational Site
state: Goias
city: Joinville
country: Brazil
facility: CON-21007 Joinville, Santa Catarina Investigational Site
state: Santa Catarina
city: Braganca Paulista
country: Brazil
facility: CON-21004 Braganca Paulista, Sao Paulo Investigational Site
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: CON-21049 Sao Paulo, Sao Paulo Investigational Site
city: Surrey
country: Canada
facility: CON-11012 Surry, BC Investigational Site
state: British Columbia
city: North York
country: Canada
facility: CON-11007 North York, ON Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: CON-11005 Sherbrooke, QC Investigational Site
state: Quebec
Study officials:
References: