Clinical Trials in India / NCT06024746
Recruiting
Phase 3
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
NCT06024746 · tracked via the Priya Life Science India tracker
Condition(s) studied
Heart Failure
Investigational drug(s) / intervention(s)
Finerenone: Oral finerenone.
Empagliflozin: Oral empagliflozin.
Study 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.
Eligibility
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 outcome measure(s)
- Clinical benefit — 6 months
Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method - Number of serious adverse events (AEs). — 6 months
\- Serious AEs (excluding efficacy endpoints). - Number of adverse events leading to discontinuation of study drug. — 6 months
\- AEs leading to discontinuation of finerenone or empagliflozin.
Trial sites (140)
| Facility | City | Region | Status |
|---|---|---|---|
| CON-10004 Fairhope, AL Investigational Site | Fairhope | Alabama | Recruiting |
| Phoenix, AZ Investigative Site CON-10115 | Phoenix | Arizona | Recruiting |
| Chula Vista, CA Investigative Site CON-10111 | Chula Vista | California | Recruiting |
| CON-10075 El Centro, CA Investigational Site | El Centro | California | Recruiting |
| CON-10024 Sacramento, CA Investigational Site | Sacramento | California | Recruiting |
| San Francisco, CA Investigative Site CON-10315 | San Francisco | California | Recruiting |
| CON-10023, San Francisco, CA | San Francisco | California | Recruiting |
| CON-10109, Van Nuys, CA | Van Nuys | California | Recruiting |
| CON-10001, Aurora, CO | Aurora | Colorado | Recruiting |
| CON-10005, Denver, CO | Denver | Colorado | Recruiting |
| Bradenton, FL Investigative Site CON-10125 | Bradenton | Florida | Recruiting |
| Fort Lauderdale, FL Investigative Site CON-10114 | Fort Lauderdale | Florida | Recruiting |
| CON-10078, Hialeah, FL | Hialeah | Florida | Recruiting |
| CON-10105, Miami, FL | Miami | Florida | Recruiting |
| CON-10113, Miramar, FL | Miramar | Florida | Recruiting |
| CON-10022 Atlanta, GA Investigational Site | Atlanta | Georgia | Recruiting |
| CON-10021, Glenview, IL | Glenview | Illinois | Recruiting |
| CON-10041, Island Lake, IL | Island Lake | Illinois | Recruiting |
| CON-10025, Naperville, IL | Naperville | Illinois | Recruiting |
| CON-10019, Peoria, IL | Peoria | Illinois | Recruiting |
| CON-10064, Merrillville, IN | Merrillville | Indiana | Recruiting |
| CON-10080, Lexington, KY | Lexington | Kentucky | Recruiting |
| Lexington, KY Investigative Site CON-10118 | Lexington | Kentucky | Recruiting |
| CON-10086, Louisville, Kentucky | Louisville | Kentucky | Recruiting |
| CON-10079, Paducah, KY | Paducah | Kentucky | Recruiting |
| CON-10030 Baton Rouge, LA Investigational Site | Baton Rouge | Louisiana | Recruiting |
| CON-10090, West Monroe, LA | West Monroe | Louisiana | Recruiting |
| Minneapolis, MN Investigative Site CON-10035 | Minneapolis | Minnesota | Recruiting |
| CON-10002 Kansas City, MO Investigative Site | Kansas City | Missouri | Recruiting |
| CON-10018, Omaha, NE | Omaha | Nebraska | Recruiting |
| CON-10318, Charlotte, NC | Charlotte | North Carolina | Recruiting |
| Greenville, NC Investigative Site CON-10122 | Greenville | North Carolina | Recruiting |
| Morrisville, NC Investigative Site CON-10317 | Morrisville | North Carolina | Recruiting |
| CON-10119, Centerville, OH | Centerville | Ohio | Recruiting |
| Philadelphia, PA Investigative Site CON-10068 | Philadelphia | Pennsylvania | Recruiting |
| CON-10051, Chattanooga, TN | Chattanooga | Tennessee | Recruiting |
| CON-10045 Amarillo, TX Investigational Site | Amarillo | Texas | Recruiting |
| CON-10015 Austin, TX Investigational Site | Austin | Texas | Recruiting |
| CON-10304, Denison, TX | Denison | Texas | Recruiting |
| CON-10301, Fort Worth, TX | Fort Worth | Texas | Recruiting |
+ 100 more sites — see the full list on the official registry below.
On this site
📄 Jardiance (empagliflozin) drug profile →More Colorado Prevention Center trials in India
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06024746 on ClinicalTrials.gov ↗ ← All trials in India