A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
This research study is investigating a new medication, BMS-986435/MYK-224, for individuals who have a specific type of heart failure known as Heart Failure with Preserved Ejection Fraction (HFpEF). This condition means your heart can pump blood, but it doesn't relax properly to fill with enough blood. The main goal of this study is to see how safe the new medication is and what side effects might happen. Researchers will also look at how the body uses and gets rid of the medicine. Some people will receive the new medicine, while others will get a placebo (a dummy pill with no active drug) to compare the effects. This is an early-stage study, meant to gather important initial information.
At a glance
What is this study about?
This study is focused on a health condition called Heart Failure with Preserved Ejection Fraction, or HFpEF for short. If you have HFpEF, it means your heart can still pump blood out to your body well, but it has trouble relaxing properly. This makes it harder for your heart to fill up with enough blood before pumping, which can lead to symptoms like shortness of breath and tiredness. Scientists are still learning the best ways to treat HFpEF, and new medications are always being explored.
In this study, researchers are testing a new potential medicine named BMS-986435/MYK-224. They want to understand if this medicine is safe for people with HFpEF and to see how their bodies react to it. This includes looking at any side effects that might occur and how the medicine moves through and is processed by the body. This type of study is an important step in finding better treatments for conditions like HFpEF.
The study is designed to compare the new medicine to a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps researchers understand if any changes or improvements are due to the new medicine or if they might have happened anyway. By carefully comparing both groups, the researchers hope to gather valuable information about BMS-986435/MYK-224.
Key takeaways
- This study is testing a new medicine for a type of heart failure called HFpEF.
- It's an early-stage study focusing on safety and how the body handles the medicine.
- Participants will receive either the new medicine or a dummy pill (placebo).
- Both men and women aged 18 and over can potentially take part.
- The study involves regular clinic visits for health checks and assessments.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To join this study, you must be an adult, aged 18 years or older. There is no upper age limit mentioned.
Both men and women are welcome to take part in this research.
Beyond these general points, there will be more detailed health requirements that a study doctor will discuss with you to make sure the study is a good fit for you and safe.
- Are you 18 years old or older?
- Do you have Heart Failure with Preserved Ejection Fraction (HFpEF)?
- Are you comfortable with the idea of taking either a new medicine or a dummy pill?
- Are you able to attend regular clinic visits and appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given either the new study medication called BMS-986435/MYK-224 or a placebo (a dummy pill with no active ingredient). You won't know which one you're receiving, and neither will your study doctor, which helps keep the results fair. You will have regular visits to the study clinic, where doctors and nurses will check your health, ask about any symptoms you're experiencing, and perform tests like blood pressure checks and blood samples. These visits will be spread out over a period of time, and you'll also have follow-up appointments after you've finished taking the medication to make sure you're well. The total duration of your participation, including all visits and follow-ups, will be explained fully by the study team.
Potential risks and benefits
Locations (3)
- —Spain
- —Poland
- —Italy
Common questions
What is Heart Failure with Preserved Ejection Fraction (HFpEF)?
HFpEF means your heart can pump blood well, but it struggles to relax properly to fill with enough blood. This causes symptoms like feeling breathless and tired.
Is this a new medicine?
Yes, BMS-986435/MYK-224 is a new medication being tested in this study to see if it's safe and how it works for HFpEF.
What does 'placebo' mean?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps ensure fair and accurate study results.
What is the main goal of this study?
The main goal is to check how safe the new medication is and to understand any side effects that might occur.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.