Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
This study is focused on a new potential medication, BMS-986435/MYK-224, for individuals living with a specific type of heart failure known as Heart Failure with Preserved Ejection Fraction (HFpEF). In HFpEF, the heart can still pump blood normally, but it has trouble relaxing and filling properly. Researchers want to thoroughly check how safe this new drug is and how well people can take it without too many bothersome side effects. They will also look at how the body handles the medicine – for example, how much of it stays in the bloodstream. The main goal is to find out if this medication could be a helpful treatment for people with HFpEF. Participants in the study will be adults aged 40 to 85, both men and women.
At a glance
What is this study about?
This research study is about a new medication, BMS-986435/MYK-224, for people who have a condition called Heart Failure with Preserved Ejection Fraction, often shortened to HFpEF. Heart failure sounds serious, but it simply means your heart isn't pumping blood as effectively as it should. In HFpEF, your heart's main pumping chamber (the left ventricle) can still push blood out well, but it becomes stiff and doesn't relax properly. This makes it harder for the heart to fill with enough blood, leading to symptoms like shortness of breath and tiredness.
The main purpose of this study is to explore how safe this new medication, BMS-986435/MYK-224, is. It’s also looking at how well people tolerate it – meaning, what side effects they might experience and how manageable they are. Additionally, the study will investigate how the body processes the medication, including how long it stays in your system. This information is a crucial step in understanding if this new drug could become a valuable treatment option for HFpEF.
Finding new ways to help people with HFpEF is important because symptoms can significantly affect daily life. This study is a 'Phase 2' trial, which means it builds on earlier research and aims to get a clearer picture of the drug's effects in a larger group of patients. By taking part, volunteers help doctors learn more about this condition and potentially improve future treatments.
Key takeaways
- This study is testing a new drug (BMS-986435/MYK-224) for HFpEF.
- It aims to check the safety and tolerability of the medication.
- Participants will be aged 40-85 with stable, symptomatic HFpEF.
- You might receive the active drug or a placebo.
- Participation involves regular clinic visits and health checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be an adult aged between 40 and 85 years old. You need to have been diagnosed with a stable form of Heart Failure with Preserved Ejection Fraction (HFpEF) and still be experiencing symptoms, even though your heart's pumping action is still considered normal.
There are also some reasons why you might not be able to participate. For example, if you have certain other heart conditions, like a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy, or certain other illnesses that might interfere with the study assessments or put you at risk, you would not be eligible. This is to ensure your safety and that the study results are clear.
The study team will carefully review your medical history and conduct tests to confirm if you meet all the necessary requirements to take part safely. They will explain everything in detail.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 40 and 85 years old?
- Do you have a diagnosis of Heart Failure with Preserved Ejection Fraction (HFpEF)?
- Are you currently experiencing symptoms from your HFpEF?
- Do you have any other serious heart conditions, like certain types of cardiomyopathy, that might rule you out?
- Are you willing and able to attend regular study visits?
What does participation involve?
If you decide to take part in this study, you will be given either the new study medication, BMS-986435/MYK-224, or a placebo. A placebo looks like the real medication but doesn't contain any active drug. This is a common way to accurately compare the effects of the new medicine. You won't know whether you're receiving the active drug or the placebo.
Your involvement will include regular visits to the study clinic. During these visits, you will have various assessments, such as physical exams, blood tests to check drug levels and your general health, and tests related to your heart condition. These assessments will help the doctors understand how the medication is affecting your body and your heart.
You will need to take the study medication as instructed. There will also be follow-up calls or visits after you finish taking the medication, to check on your health. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you by the study team.
Potential risks and benefits
Locations (117)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- Colorado Heart and Vascular - LakewoodVerified postcodeLakewood, United States· Recruiting
- Ascension St. Vincent's Riverside Hospital - PPDSVerified postcodeJacksonville, United States· Recruiting
- Local Institution - 0003Verified postcodeMiami, United States· Active not recruiting
- University of Miami FL Miller School of Medicine -1120 NW 14th StVerified postcodeMiami, United States· Recruiting
- Local Institution - 0014Verified postcodeAtlanta, United States· Withdrawn
- Local Institution - 0048Verified postcodeAtlanta, United States· Withdrawn
- Bluhm Cardiovascular Institute of NorthwesternVerified postcodeChicago, United States· Recruiting
- Chicago Medical Research, LLC - Hazel CrestVerified postcodeHazel Crest, United States· Recruiting
- Ascension Medical Group St. Vincent - Indianapolis Heart CareVerified postcodeIndianapolis, United States· Recruiting
- Local Institution - 0045Verified postcodeIndianapolis, United States· Withdrawn
- St. Louis Heart and VascularVerified postcodeSt Louis, United States· Recruiting
Common questions
What is HFpEF?
HFpEF stands for Heart Failure with Preserved Ejection Fraction. It means your heart can pump blood well, but it has trouble relaxing to fill properly, which can cause symptoms like breathlessness.
What is a 'Phase 2' study?
Phase 2 studies are early-stage trials that look closely at the safety of a new medicine and how much of it is needed, usually in a smaller group of people who have the condition.
Will I definitely get the new medication?
You will either receive the new medication or a placebo (a dummy pill). This helps researchers fairly compare how well the new medicine works.
How long will I be in the study?
The study team will tell you the exact length of your participation, including all visits and follow-ups, during the consent process.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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