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A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) (CONFIRMATION)

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finerenone
Empagliflozin
Sponsored by
Colorado Prevention Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Hospitalized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years or legal age of majority 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 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 Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or serum/plasma potassium >5.0 mmol/L Type 1 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 Any other condition or therapy which would make the patient unsuitable for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Finerenone plus empagliflozin

    Usual care

    Arm Description

    Usual care management

    Outcomes

    Primary Outcome Measures

    Clinical benefit
    Hierarchical composite of the following assessed by the win-ratio: Time to death from any cause Number of HF events Time to first HF event Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)
    Number of serious adverse events (AEs).
    - Serious AEs (excluding efficacy endpoints).
    Number of adverse events leading to discontinuation of study drug.
    - AEs leading to discontinuation of finerenone or empagliflozin.

    Secondary Outcome Measures

    Number of deaths from any cause and total HF events.
    - All-cause mortality and total HF events (first and recurrent).
    Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
    Number of HF events at Day 90.
    - Total (first and recurrent) HF events.

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Colorado Prevention Center
    Collaborators
    Saint Luke's Hospital of Kansas City, Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06024746
    Brief Title
    A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
    Acronym
    CONFIRMATION
    Official Title
    Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Colorado Prevention Center
    Collaborators
    Saint Luke's Hospital of Kansas City, Bayer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Combination therapy with finerenone with empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
    Detailed Description
    This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Heart Failure, Hospitalized

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Finerenone plus empagliflozin
    Arm Type
    Experimental
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Usual care management
    Intervention Type
    Drug
    Intervention Name(s)
    Finerenone
    Intervention Description
    Oral finerenone.
    Intervention Type
    Drug
    Intervention Name(s)
    Empagliflozin
    Intervention Description
    Oral empagliflozin.
    Primary Outcome Measure Information:
    Title
    Clinical benefit
    Description
    Hierarchical composite of the following assessed by the win-ratio: Time to death from any cause Number of HF events Time to first HF event Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)
    Time Frame
    6 months
    Title
    Number of serious adverse events (AEs).
    Description
    - Serious AEs (excluding efficacy endpoints).
    Time Frame
    6 months
    Title
    Number of adverse events leading to discontinuation of study drug.
    Description
    - AEs leading to discontinuation of finerenone or empagliflozin.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of deaths from any cause and total HF events.
    Description
    - All-cause mortality and total HF events (first and recurrent).
    Time Frame
    6 months
    Title
    Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
    Time Frame
    6 months
    Title
    Number of HF events at Day 90.
    Description
    - Total (first and recurrent) HF events.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years or legal age of majority 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 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 Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or serum/plasma potassium >5.0 mmol/L Type 1 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 Any other condition or therapy which would make the patient unsuitable for this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc Bonaca
    Phone
    (303) 860-9900
    Email
    info@cpcmed.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No current plan to share individual patient data with other researchers.

    Learn more about this trial

    A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

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