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A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finerenone
Placebo
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 Reduced ejection fraction, Symptomatic heart failure

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 Symptomatic HFrEF per protocol defined criteria Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: Treatment with non-steroidal MRA (nsMRA) eGFR < 25 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 or planned Prior or planned heart transplant Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure Symptomatic bradycardia or second- or third-degree heart block without a pacemaker Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction Probable alternative cause of participant's HF Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers Any other condition or therapy which would make the participant unsuitable for the study Concurrent participation in another interventional clinical study using an investigational agent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Finerenone

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time to first occurrence of cardiovascular (CV) death or HF event.
    - Time to first CV death or HF event with finerenone compared to placebo.
    Number of serious adverse events
    - Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
    Number of adverse events leading to discontinuation of study drug.
    - Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.

    Secondary Outcome Measures

    Timing and occurrence of total HF events and CV deaths.
    - Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.
    Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180.
    - Change in KCCQ-TSS with finerenone compared to placebo.
    Time to first occurrence of composite kidney endpoint.
    Composite endpoint: Estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo.
    Time to CV death.
    - Time to CV death with finerenone compared to placebo.
    Time to death from any cause.
    - Time to all-cause mortality with finerenone compared to placebo.

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    September 20, 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
    NCT06033950
    Brief Title
    A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists
    Acronym
    FINALITY-HF
    Official Title
    A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2024 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    November 2027 (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
    Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonist (sMRA).
    Detailed Description
    This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Reduced ejection fraction, Symptomatic heart failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Finerenone
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Finerenone
    Intervention Description
    Oral finerenone.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching oral placebo.
    Primary Outcome Measure Information:
    Title
    Time to first occurrence of cardiovascular (CV) death or HF event.
    Description
    - Time to first CV death or HF event with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of serious adverse events
    Description
    - Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Number of adverse events leading to discontinuation of study drug.
    Description
    - Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Secondary Outcome Measure Information:
    Title
    Timing and occurrence of total HF events and CV deaths.
    Description
    - Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180.
    Description
    - Change in KCCQ-TSS with finerenone compared to placebo.
    Time Frame
    180 days
    Title
    Time to first occurrence of composite kidney endpoint.
    Description
    Composite endpoint: Estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Time to CV death.
    Description
    - Time to CV death with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months
    Title
    Time to death from any cause.
    Description
    - Time to all-cause mortality with finerenone compared to placebo.
    Time Frame
    Ongoing, up to ~30 months

    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 Symptomatic HFrEF per protocol defined criteria Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: Treatment with non-steroidal MRA (nsMRA) eGFR < 25 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 or planned Prior or planned heart transplant Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure Symptomatic bradycardia or second- or third-degree heart block without a pacemaker Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction Probable alternative cause of participant's HF Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers Any other condition or therapy which would make the participant unsuitable for the study Concurrent participation in another interventional clinical study using an investigational agent
    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

    Learn more about this trial

    A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists

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