Heart Failure study: Finerenone vs Empagliflozin
Official title A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
ClinicalTrials.gov ID: NCT06024746
What this study is testing
What is Finerenone?
This is an investigational oral medicine being studied to see if it helps treat heart failure. It is designed to block a hormone receptor in the body that can cause fluid retention and stress on the heart.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether using finerenone and empagliflozin together works well. It also checks how safe this mix is for people in the hospital.
- Who it's for
- You may be able to join if you are in the hospital for heart failure.
- What's involved
- You would take finerenone and empagliflozin. The team will compare this to your usual care.
- Time commitment
- The study lasts while you are in the hospital for heart failure.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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) \ 5.0 mmol/L
- Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device...
- Prior or planned heart transplant
See the full eligibility 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
- Fulfillment of protocol defined stabilization criteria (if assigned by chance 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)
- 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) \ 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Phoenix, Arizona, United States
- Chula Vista, California, United States
- El Centro, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Van Nuys, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Bradenton, Florida, United States
- Fort Lauderdale, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miramar, Florida, United States
- Atlanta, Georgia, United States
- Glenview, Illinois, United States
- Island Lake, Illinois, United States
- Naperville, Illinois, United States
- Peoria, Illinois, United States
- Merrillville, Indiana, United States
+ 98 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fairhope, Alabama, United States; Phoenix, Arizona, United States; Chula Vista, California, United States; El Centro, California, United States; Sacramento, California, United States; San Francisco, California, United States and 112 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.