NCT06024746 · Colorado Prevention Center
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
(CONFIRMATION)
What this study is about
two or more treatments used together of finerenone plus empagliflozin will be compared to usual care to determine the effectiveness and safety of treatment in patients hospitalized with heart failure.
View original scientific description
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.
Interventions
DRUG
Finerenone
Oral finerenone.
DRUG
Empagliflozin
Oral empagliflozin.
Primary outcome measures
Clinical benefit
Time frame: 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).
Time frame: 6 months
\- Serious AEs (excluding efficacy endpoints).
Number of adverse events leading to discontinuation of study drug.
Time frame: 6 months
\- AEs leading to discontinuation of finerenone or empagliflozin.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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., furos
Where
- Fairhope, Alabama
- El Centro, California
- Sacramento, California
- Atlanta, Georgia
- Baton Rouge, Louisiana
- Kansas City, Missouri
- Amarillo, Texas
- Austin, Texas
Collaborators
Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2025 · Source of record for eligibility and locations