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Tests treatment safety and results for Heart Failure
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?
Finerenone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure.
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
- 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.
- 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; or elevated NTproBNP ≥1500 pg/mL or BNP...
- 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's taking place
- Fairhope, Alabama, United States
- El Centro, California, United States
- Sacramento, California, United States
- Atlanta, Georgia, United States
- Baton Rouge, Louisiana, United States
- Kansas City, Missouri, United States
- Amarillo, Texas, United States
- Austin, Texas, United States
- Goiânia, Goiás, Brazil
- Joinville, Santa Catarina, Brazil
- Bragança Paulista, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Surrey, British Columbia, Canada
- North York, Ontario, Canada
- Sherbrooke, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Fairhope, Alabama, United States; El Centro, California, United States; Sacramento, California, United States; Atlanta, Georgia, United States; Baton Rouge, Louisiana, United States; Kansas City, Missouri, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.