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A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

RecruitingPhase 3

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

Ages 18 and older · All sexes

Full 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

About the 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.

What is being tested

Sponsor: Colorado Prevention Center · Participants: 1,500 · Started: Jul 9, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06024746

Locations in the U.S.

AlabamaCON-10004 Fairhope, AL Investigational Site, Fairhope
ArizonaPhoenix, AZ Investigative Site CON-10115, Phoenix
CaliforniaChula Vista, CA Investigative Site CON-10111, Chula Vista
CON-10075 El Centro, CA Investigational Site, El Centro
CON-10024 Sacramento, CA Investigational Site, Sacramento
CON-10023, San Francisco, CA, San Francisco
San Francisco, CA Investigative Site CON-10315, San Francisco
CON-10109, Van Nuys, CA, Van Nuys
ColoradoCON-10001, Aurora, CO, Aurora
CON-10005, Denver, CO, Denver
FloridaBradenton, FL Investigative Site CON-10125, Bradenton
Fort Lauderdale, FL Investigative Site CON-10114, Fort Lauderdale
CON-10078, Hialeah, FL, Hialeah
CON-10105, Miami, FL, Miami
CON-10113, Miramar, FL, Miramar
GeorgiaCON-10022 Atlanta, GA Investigational Site, Atlanta
IllinoisCON-10021, Glenview, IL, Glenview
CON-10041, Island Lake, IL, Island Lake
CON-10025, Naperville, IL, Naperville
CON-10019, Peoria, IL, Peoria
IndianaCON-10064, Merrillville, IN, Merrillville
KentuckyCON-10080, Lexington, KY, Lexington
Lexington, KY Investigative Site CON-10118, Lexington
CON-10086, Louisville, Kentucky, Louisville
CON-10079, Paducah, KY, Paducah
LouisianaCON-10030 Baton Rouge, LA Investigational Site, Baton Rouge
CON-10090, West Monroe, LA, West Monroe
MinnesotaMinneapolis, MN Investigative Site CON-10035, Minneapolis
MissouriCON-10002 Kansas City, MO Investigative Site, Kansas City
NebraskaCON-10018, Omaha, NE, Omaha
North CarolinaCON-10318, Charlotte, NC, Charlotte
Greenville, NC Investigative Site CON-10122, Greenville
Morrisville, NC Investigative Site CON-10317, Morrisville
OhioCON-10119, Centerville, OH, Centerville
PennsylvaniaPhiladelphia, PA Investigative Site CON-10068, Philadelphia
TennesseeCON-10051, Chattanooga, TN, Chattanooga
TexasCON-10045 Amarillo, TX Investigational Site, Amarillo
CON-10015 Austin, TX Investigational Site, Austin
CON-10304, Denison, TX, Denison
CON-10301, Fort Worth, TX, Fort Worth
CON-10085, Houston, TX, Houston
Houston, TX Investigative Site CON-10320, Houston
Texarkana, TX Investigative Site CON-10319, Texarkana
UtahCON-10305, Layton, UT, Layton
VirginiaCON-10009, Norfolk, VA, Norfolk
Salem, VA Investigative Site CON-10048, Salem

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.