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JXR CARD ORTE FINALITY

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Description

This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.

Details

Full study 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
Protocol number OCR48951
ClinicalTrials.gov ID NCT06033950
Phase Phase 3

Eligibility

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

  • 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)

  • Documented prior history of severe hyperkalemia in the setting of MRA use

  • eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L

  • 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

  • Known hypersensitivity to the IP (active substance or excipients)

  • Any other condition or therapy which would make the participant unsuitable for the study

  • Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.