A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
Recruiting · NCT06024746 · Interventional (participants receive a specific treatment) · Lead sponsor: Colorado Prevention Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 20 US states.
- CON-10004 Fairhope, AL Investigational Site - Fairhope, Alabama, United States
- Phoenix, AZ Investigative Site CON-10115 - Phoenix, Arizona, United States
- Chula Vista, CA Investigative Site CON-10111 - Chula Vista, California, United States
- CON-10075 El Centro, CA Investigational Site - El Centro, California, United States
- CON-10024 Sacramento, CA Investigational Site - Sacramento, California, United States
- San Francisco, CA Investigative Site CON-10315 - San Francisco, California, United States
- CON-10023, San Francisco, CA - San Francisco, California, United States
- CON-10109, Van Nuys, CA - Van Nuys, California, United States
- CON-10001, Aurora, CO - Aurora, Colorado, United States
- CON-10005, Denver, CO - Denver, Colorado, United States
- Bradenton, FL Investigative Site CON-10125 - Bradenton, Florida, United States
- Fort Lauderdale, FL Investigative Site CON-10114 - Fort Lauderdale, Florida, United States
- CON-10078, Hialeah, FL - Hialeah, Florida, United States
- CON-10105, Miami, FL - Miami, Florida, United States
- CON-10113, Miramar, FL - Miramar, Florida, United States
- CON-10022 Atlanta, GA Investigational Site - Atlanta, Georgia, United States
- CON-10021, Glenview, IL - Glenview, Illinois, United States
- CON-10041, Island Lake, IL - Island Lake, Illinois, United States
- CON-10025, Naperville, IL - Naperville, Illinois, United States
- CON-10019, Peoria, IL - Peoria, Illinois, United States
- CON-10064, Merrillville, IN - Merrillville, Indiana, United States
- CON-10080, Lexington, KY - Lexington, Kentucky, United States
- Lexington, KY Investigative Site CON-10118 - Lexington, Kentucky, United States
- CON-10086, Louisville, Kentucky - Louisville, Kentucky, United States
- CON-10079, Paducah, KY - Paducah, Kentucky, United States
- CON-10030 Baton Rouge, LA Investigational Site - Baton Rouge, Louisiana, United States
- CON-10090, West Monroe, LA - West Monroe, Louisiana, United States
- Minneapolis, MN Investigative Site CON-10035 - Minneapolis, Minnesota, United States
- CON-10002 Kansas City, MO Investigative Site - Kansas City, Missouri, United States
- CON-10018, Omaha, NE - Omaha, Nebraska, United States
- CON-10318, Charlotte, NC - Charlotte, North Carolina, United States
- Greenville, NC Investigative Site CON-10122 - Greenville, North Carolina, United States
- Morrisville, NC Investigative Site CON-10317 - Morrisville, North Carolina, United States
- CON-10119, Centerville, OH - Centerville, Ohio, United States
- Philadelphia, PA Investigative Site CON-10068 - Philadelphia, Pennsylvania, United States
- CON-10051, Chattanooga, TN - Chattanooga, Tennessee, United States
- CON-10045 Amarillo, TX Investigational Site - Amarillo, Texas, United States
- CON-10015 Austin, TX Investigational Site - Austin, Texas, United States
- CON-10304, Denison, TX - Denison, Texas, United States
- CON-10301, Fort Worth, TX - Fort Worth, Texas, United States
- CON-10085, Houston, TX - Houston, Texas, United States
- Houston, TX Investigative Site CON-10320 - Houston, Texas, United States
- Texarkana, TX Investigative Site CON-10319 - Texarkana, Texas, United States
- CON-10305, Layton, UT - Layton, Utah, United States
- CON-10009, Norfolk, VA - Norfolk, Virginia, United States
- Salem, VA Investigative Site CON-10048 - Salem, Virginia, United States
- Barcelona Investigative Site CON-38010 - Barcelona, Spain
- CON-39007, Bristol, UK - Bristol, United Kingdom
- CON-39001, Glasgow, UK - Glasgow, United Kingdom
- New Delhi, Delhi Investigative Site CON-51004 - New Delhi, India
- Porto Alegre, RS Investigative Site CON-21019 - Porto Alegre, Brazil
- Shanghai, China Investigative Site CON-56011 - Shanghai, China
- São Paulo Investigative Site CON-21066 - São Paulo, Brazil
- Valencia Investigative Site CON-38007 - Valencia, Spain
- CON-21036, Rio Branco, Acre - Rio Branco, Acre, Brazil
- CON-21064, Arapiraca, Alagoas, Brazil - Arapiraca, Alagoas, Brazil
- CON-11011, Edmonton, AB - Edmonton, Alberta, Canada
- CON-11012 Surry, BC Investigational Site - Surrey, British Columbia, Canada
- Fortaleza, Ceará Investigative Site CON-21076 - Fortaleza, Ceará, Brazil
- Fortaleza, Ceará Investigative Site CON-21055 - Fortaleza, Ceará, Brazil
Showing 60 of 140 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →