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Study on the Safety and Tolerability of BMS-986435 in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Heart Failure with Preserved Ejection Fraction (HFpEF). This is a type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats. The trial will evaluate a new treatment called BMS-986435/MYK-224, which is being developed to help manage this condition. Participants in the study will receive either the new treatment or a placebo, which is a substance with no active medication.

The purpose of the study is to understand the safety and tolerability of MYK-224 in individuals with HFpEF. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. Participants will take the medication in the form of a tablet, which is taken orally. The study will monitor the number of side effects experienced by participants and measure the amount of the drug in the bloodstream to gather important information about how the body processes the medication.

The trial is expected to run until early 2025, with recruitment starting in 2024. This study aims to provide valuable insights into the potential benefits and risks of using MYK-224 for treating HFpEF, ultimately contributing to better management of this heart condition. Participants will be closely monitored throughout the study to ensure their safety and to collect data that will help researchers understand the effects of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals with stable, symptomatic heart failure with preserved ejection fraction (HFpEF) and normal heart pumping ability.

  2. Step 2

    Randomization and medication

    Participants are randomly assigned to receive either the study medication, BMS-986435, or a placebo. The medication is administered in the form of a tablet taken orally.

  3. Step 3

    Medication administration

    The study medication or placebo is taken as prescribed. The specific dosage and frequency are determined by the study protocol and communicated to participants at the start of the trial.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to evaluate the safety and tolerability of the medication. This includes tracking any side effects experienced during the trial.

  5. Step 5

    Blood sample collection

    Blood samples are collected at specified intervals to measure the amount of MYK-224 in the bloodstream, which helps assess how the body processes the medication.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by February 1, 2025. Participants will be informed of the study's completion and any follow-up procedures.

Who can join the trial?

5 criteria

  • Participants must be adults, which means they should be 18 years or older.
  • Participants should have a condition called Heart Failure with Preserved Ejection Fraction (HFpEF). This means their heart has trouble relaxing and filling with blood, but it still pumps normally.
  • Participants must have stable symptoms, meaning their condition is not getting worse quickly.
  • Both men and women can participate in the study.
  • Participants should not be part of a vulnerable population, which means they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who cannot join the trial?

10 criteria

  • Participants with a history of severe allergic reactions to the study medication or its ingredients.
  • Individuals with other serious heart conditions that are not related to Heart Failure with Preserved Ejection Fraction (HFpEF). HFpEF is a type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats.
  • People with severe kidney or liver disease.
  • Participants who have had a heart attack or stroke within the last 6 months.
  • Individuals who are currently participating in another clinical trial.
  • Pregnant or breastfeeding women.
  • People with uncontrolled high blood pressure.
  • Individuals with a history of drug or alcohol abuse within the past year.
  • Participants who have been diagnosed with cancer in the past 5 years, except for certain types of skin cancer.
  • Individuals with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

BMS-986435/MYK-224 is a medication being studied for its effects on heart failure with preserved ejection fraction (HFpEF). The trial aims to understand how safe and tolerable this medication is for participants with this type of heart failure. The study will also look at how the body processes the medication and how it affects the heart condition.

What is already known about the treatment

MYK-224 – This medication is administered orally and is currently being studied in clinical trials for its safety and tolerability in treating heart failure with preserved ejection fraction (HFpEF). It is in the investigational stage, meaning it is not yet approved for general medical use, but it is being evaluated in medical research. The main therapeutic indication for MYK-224 is to address HFpEF, a condition where the heart muscle contracts normally but the ventricles do not relax as they should. At the molecular level, MYK-224 is believed to work by modulating cardiac muscle function, although the exact mechanism is still under investigation. It falls under the pharmacological classification of cardiac modulators.

Investigated diseases

Heart Failure with Preserved Ejection Fraction (HFpEF) – This condition occurs when the heart's lower chambers, known as ventricles, are unable to relax properly and fill with blood, despite the heart's ability to pump blood effectively. As a result, the heart cannot supply enough blood to meet the body's needs, leading to symptoms such as shortness of breath, fatigue, and fluid retention. HFpEF is often associated with aging and is more common in individuals with high blood pressure, diabetes, or obesity. Over time, the heart muscle may become stiffer, further impairing its ability to fill with blood. This condition can lead to a reduced quality of life due to the persistent symptoms and limitations on physical activity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505919-21-00Protocol codeCV029-1001Estimated enrolment55 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).