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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Fondazione Toscana Gabriele Monasterio Pisa Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Uldr Ckyjdvhz Tmkekz Ssc z ovhr Lodz Poland
Aindaid Odwpigichnz Pxlb Gpoqljyg Xzovc Bergamo Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.04.2024
Poland Poland
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024

Trial locations

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.

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 ID:
2023-505919-21-00
Protocol code:
CV029-1001
NCT ID:
NCT06122779
Trial Phase:
Therapeutic exploratory (Phase II)

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