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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)

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ClinicalTrials.gov Identifier: NCT06033950
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : April 17, 2024
Sponsor:
Collaborators:
Saint Luke's Hospital of Kansas City
Bayer
Information provided by (Responsible Party):
Colorado Prevention Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Finerenone Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Finerenone Drug: Finerenone
Oral finerenone.
Placebo Comparator: Placebo Drug: Placebo
Matching oral placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of cardiovascular (CV) death or HF event. [ Time Frame: Ongoing, up to ~30 months ]
    - Time to first CV death or HF event with finerenone compared to placebo.

  2. Number of serious adverse events [ Time Frame: Ongoing, up to ~30 months ]
    - Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.

  3. Number of adverse events leading to discontinuation of study drug. [ Time Frame: Ongoing, up to ~30 months ]
    - Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.


Secondary Outcome Measures :
  1. Timing and occurrence of total HF events and CV deaths. [ Time Frame: Ongoing, up to ~30 months ]
    - Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.

  2. Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180. [ Time Frame: 180 days ]
    - Change in KCCQ-TSS with finerenone compared to placebo.

  3. Time to first occurrence of composite kidney endpoint. [ Time Frame: Ongoing, up to ~30 months ]

    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.

  4. Time to CV death. [ Time Frame: Ongoing, up to ~30 months ]
    - Time to CV death with finerenone compared to placebo.

  5. Time to death from any cause. [ Time Frame: Ongoing, up to ~30 months ]
    - Time to all-cause mortality with finerenone compared to placebo.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033950


Contacts
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Contact: Marc Bonaca (303) 860-9900 info@cpcmed.org

Sponsors and Collaborators
Colorado Prevention Center
Saint Luke's Hospital of Kansas City
Bayer
More Information
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Responsible Party: Colorado Prevention Center
ClinicalTrials.gov Identifier: NCT06033950    
Other Study ID Numbers: 202304CPC
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colorado Prevention Center:
Reduced ejection fraction
Symptomatic heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases