A Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (MERCUTIO)
This study, called MERCUTIO, is testing a new medicine called MYK-224 for adults with a specific heart condition: symptomatic hypertrophic cardiomyopathy with a blockage in the heart's main artery. We want to understand if this new medicine is safe and well-tolerated. Researchers will also learn how the medicine behaves in the body and if it helps improve heart function and reduce symptoms. By closely monitoring participants, we aim to find out if MYK-224 could be a helpful treatment option for people living with this condition, ultimately looking for ways to improve their quality of life. This is an early-stage study, meaning we are learning the basics about the medicine.
At a glance
What is this study about?
This study is investigating a new medicine called MYK-224. It's for people who have a heart condition called hypertrophic cardiomyopathy (HCM). In HCM, the heart muscle becomes unusually thick, making it harder for the heart to pump blood effectively. For some people with HCM, this thickening can cause a blockage where the blood leaves the heart, leading to symptoms like shortness of breath, chest pain, and feeling faint. The study specificially focuses on individuals who experience these noticeable symptoms and have this blockage.
The main goals of this study are to carefully check how safe the new medicine MYK-224 is and how well people tolerate it. Researchers will also be looking at how the medicine works in the body and if it can help improve heart function and symptoms like the blockage mentioned earlier. They will track things like how participants feel, their heart's pumping ability, and any heart rhythm changes.
This is a 'Phase 2a' study, which means it's an important early stage of research. It's about exploring whether the medicine could be effective and finding out the right dose to use. The findings from this study will help us understand if MYK-224 has the potential to become a new treatment option for people with this specific type of heart condition.
Key takeaways
- This study is testing a new medicine (MYK-224) for a specific heart condition.
- It's for adults with hypertrophic cardiomyopathy who have symptoms and a heart blockage.
- The main goals are to check the medicine's safety, how it works, and if it helps symptoms.
- Participants will have regular check-ups, including heart tests and blood tests.
- This is an early-stage study to gather important information about MYK-224.
Who may be eligible?
This study is looking for adult volunteers, meaning you must be at least 18 years old to take part. There is no upper age limit, so people of all adult ages are welcome to be considered.
To be eligible, you must have been diagnosed with symptomatic hypertrophic cardiomyopathy. This means your heart muscle is thickened, and you experience symptoms related to it, such as breathlessness or chest pain. You must also have a specific type of blockage where blood leaves the heart.
Both men and women can join this study. The study team will carefully check other specific health details to make sure the study is safe and appropriate for everyone involved.
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 18 years old or over?
- Have you been diagnosed with hypertrophic cardiomyopathy that causes symptoms?
- Do you have a blockage where blood leaves your heart?
- Are you able to attend regular clinic appointments for monitoring?
What does participation involve?
If you decide to take part in this study, you'll be given the new medicine, MYK-224. The study involves regular visits to the clinic where the doctors and nurses will monitor your health closely. During these visits, you can expect to have various checks, like physical examinations, blood tests, and heart tracings (ECGs) to see how your heart is working. They might also do special heart scans like echocardiograms to measure how well your heart is pumping and if the blockage is improving.
The study team will be looking out for any side effects you might experience and will ask you about your symptoms. They will explain exactly what taking part involves, including the schedule of visits and how long you'll be in the study, which will be for a set period. It's important to remember that throughout the study, your health will be closely supervised.
Potential risks and benefits
Locations (3)
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Common questions
What is hypertrophic cardiomyopathy?
It's a heart condition where the heart muscle becomes unusually thick, making it harder for the heart to pump blood around the body effectively.
What does 'symptomatic' mean in this study?
It means you are experiencing noticeable symptoms from your heart condition, like shortness of breath or chest pain.
What phase is this study?
This is a Phase 2a study, which is an early stage of research looking into the medicine's effectiveness and safety after initial testing.
Will I definitely get the new medicine?
Yes, in this specific study, all participants will receive the investigational medicine MYK-224.
Can I leave the study if I change my mind?
Yes, you have the right to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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