A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (46)
AL
- CON-10004 Fairhope, AL Investigational Site · Fairhope, AL 36532More trials in Fairhope
AZ
- Phoenix, AZ Investigative Site CON-10115 · Phoenix, AZ 85006Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Phoenix
CA
- Chula Vista, CA Investigative Site CON-10111 · Chula Vista, CA 91911Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Chula Vista
- CON-10075 El Centro, CA Investigational Site · El Centro, CA 92243More trials in El Centro
- CON-10024 Sacramento, CA Investigational Site · Sacramento, CA 95816More trials in Sacramento
- San Francisco, CA Investigative Site CON-10315 · San Francisco, CA 94110Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Francisco
- CON-10023, San Francisco, CA · San Francisco, CA 94118Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Francisco
- CON-10109, Van Nuys, CA · Van Nuys, CA 91405Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Van Nuys
CO
- CON-10001, Aurora, CO · Aurora, CO 80045Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Aurora
- CON-10005, Denver, CO · Denver, CO 80204Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Denver
FL
- Bradenton, FL Investigative Site CON-10125 · Bradenton, FL 34209Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Bradenton
- Fort Lauderdale, FL Investigative Site CON-10114 · Fort Lauderdale, FL 33308Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fort Lauderdale
- CON-10078, Hialeah, FL · Hialeah, FL 33012Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Hialeah
- CON-10105, Miami, FL · Miami, FL 33135Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Miami
- CON-10113, Miramar, FL · Miramar, FL 33027Bonaca, MD · Study contact · 3038609900 · info@cpcmed.orgMore trials in Miramar
GA
- CON-10022 Atlanta, GA Investigational Site · Atlanta, GA 30303More trials in Atlanta
IL
- CON-10021, Glenview, IL · Glenview, IL 60026Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Glenview
- CON-10041, Island Lake, IL · Island Lake, IL 60042Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Island Lake
- CON-10025, Naperville, IL · Naperville, IL 60540Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Naperville
- CON-10019, Peoria, IL · Peoria, IL 61603Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Peoria
IN
- CON-10064, Merrillville, IN · Merrillville, IN 46410Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Merrillville
KY
- CON-10080, Lexington, KY · Lexington, KY 40503Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- Lexington, KY Investigative Site CON-10118 · Lexington, KY 40536Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- CON-10086, Louisville, Kentucky · Louisville, KY 40205Bonaca, MD · Study contact · 3038609900 · info@cpcmed.orgMore trials in Louisville
- CON-10079, Paducah, KY · Paducah, KY 42003Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Paducah
LA
- CON-10030 Baton Rouge, LA Investigational Site · Baton Rouge, LA 70808More trials in Baton Rouge
- CON-10090, West Monroe, LA · West Monroe, LA 71291Bonaca, MD · Study contact · 3038609900 · info@cpcmed.orgMore trials in West Monroe
MN
- Minneapolis, MN Investigative Site CON-10035 · Minneapolis, MN 55417Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Minneapolis
MO
- CON-10002 Kansas City, MO Investigative Site · Kansas City, MO 64111Marc Bonaca · Study contactMore trials in Kansas City
NC
- CON-10318, Charlotte, NC · Charlotte, NC 28207Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Charlotte
- Greenville, NC Investigative Site CON-10122 · Greenville, NC 27834Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Greenville
- Morrisville, NC Investigative Site CON-10317 · Morrisville, NC 27560Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Morrisville
NE
- CON-10018, Omaha, NE · Omaha, NE 68105Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Omaha
OH
- CON-10119, Centerville, OH · Centerville, OH 45459Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Centerville
PA
- Philadelphia, PA Investigative Site CON-10068 · Philadelphia, PA 19107Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Philadelphia
TN
- CON-10051, Chattanooga, TN · Chattanooga, TN 37403Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Chattanooga
TX
- CON-10045 Amarillo, TX Investigational Site · Amarillo, TX 79106More trials in Amarillo
- CON-10015 Austin, TX Investigational Site · Austin, TX 78705More trials in Austin
- CON-10304, Denison, TX · Denison, TX 75020Bonaca, MD · Study contact · 3038609900 · info@cpcmed.orgMore trials in Denison
- CON-10301, Fort Worth, TX · Fort Worth, TX 76104Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fort Worth
- CON-10085, Houston, TX · Houston, TX 77030Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Houston
- Houston, TX Investigative Site CON-10320 · Houston, TX 77058Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Houston
- Texarkana, TX Investigative Site CON-10319 · Texarkana, TX 75503Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Texarkana
UT
- CON-10305, Layton, UT · Layton, UT 84041 · Study contact · 3038609900 · info@cpcmed.orgMore trials in Layton
VA
- CON-10009, Norfolk, VA · Norfolk, VA 23507Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Norfolk
- Salem, VA Investigative Site CON-10048 · Salem, VA 24153Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Salem