Actively Recruiting
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
Led by Colorado Prevention Center · Updated on 2025-03-11
1500
Participants Needed
15
Research Sites
107 weeks
Total Duration
On this page
Sponsors
C
Colorado Prevention Center
Lead Sponsor
S
Saint Luke's Mid America Heart Institute
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
- Age 18 years or older or legal age of majority if over 18 years in the participant's country
- Currently hospitalized or recently discharged with the primary diagnosis of heart failure
- Heart failure signs and symptoms present at the time of hospital admission
- Elevated NTproBNP of at least 500 pg/mL or BNP of at least 125 pg/mL for patients in sinus rhythm, or elevated NTproBNP of at least 1500 pg/mL or BNP of at least 375 pg/mL for patients with atrial fibrillation, measured during current hospitalization or within 72 hours before admission
- Fulfillment of protocol-defined stabilization criteria if randomized during hospitalization
- Treatment during the current hospitalization with at least one 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)
You will not qualify if you...
- Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
- Documented prior history of severe hyperkalemia during mineralocorticoid receptor antagonist use
- Treatment with non-steroidal mineralocorticoid receptor antagonists or SGLT2 inhibitors
- Estimated glomerular filtration rate below 30 mL/min/1.73m² and/or potassium level above 5.0 mmol/L
- Acute myocardial infarction, coronary revascularization, valve surgery, or cardiac resynchronization therapy device implantation within 30 days
- Prior or planned heart transplant
- 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, reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
- Likely alternative cause of heart failure symptoms
- Use of potent cytochrome P450 isoenzyme 3A4 inhibitors or moderate/strong CYP3A4 inducers
- Known hypersensitivity to the investigational product or its ingredients
- Any other condition or therapy making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
CON-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, United States, 36532
Actively Recruiting
2
CON-10075 El Centro, CA Investigational Site
El Centro, California, United States, 92243
Actively Recruiting
3
CON-10024 Sacramento, CA Investigational Site
Sacramento, California, United States, 95816
Actively Recruiting
4
CON-10022 Atlanta, GA Investigational Site
Atlanta, Georgia, United States, 30303
Actively Recruiting
5
CON-10030 Baton Rouge, LA Investigational Site
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
6
CON-10002 Kansas City, MO Investigative Site
Kansas City, Missouri, United States, 64111
Actively Recruiting
7
CON-10045 Amarillo, TX Investigational Site
Amarillo, Texas, United States, 79106
Actively Recruiting
8
CON-10015 Austin, TX Investigational Site
Austin, Texas, United States, 78705
Actively Recruiting
9
CON-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, Brazil, 74453-200
Actively Recruiting
10
CON-21007 Joinville, Santa Catarina Investigational Site
Joinville, Santa Catarina, Brazil, 89200-000
Actively Recruiting
11
CON-21004 Braganca Paulista, Sao Paulo Investigational Site
Bragança Paulista, São Paulo, Brazil, 12916542
Actively Recruiting
12
CON-21049 Sao Paulo, Sao Paulo Investigational Site
São Paulo, São Paulo, Brazil, 05652-900
Actively Recruiting
13
CON-11012 Surry, BC Investigational Site
Surrey, British Columbia, Canada, V3V OC6
Actively Recruiting
14
CON-11007 North York, ON Investigational Site
North York, Ontario, Canada, M6B 3H7
Actively Recruiting
15
CON-11005 Sherbrooke, QC Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
Research Team
M
Marc Bonaca
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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