A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICKHCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)
This research is a continuation study focusing on the long-term safety of a medicine called mavacamten for adults living with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle thickens, making it harder for the heart to pump blood effectively. Participants in this study have already taken mavacamten in two earlier studies (MAVERICK-HCM or EXPLORER-HCM). The main aim is to carefully monitor for any health problems, especially those related to the heart, over a longer period. Researchers will track events like heart attacks, strokes, hospital stays, and any new or worsening heart symptoms to ensure the medicine is safe when used long-term.
At a glance
What is this study about?
This study is a long-term follow-up for people who have previously taken part in trials testing a new medicine called mavacamten. This medicine is for adults who have a heart condition called hypertrophic cardiomyopathy (HCM). In HCM, the heart muscle becomes unusually thick, which can sometimes make it harder for the heart to pump blood and can cause symptoms like breathlessness, chest pain, or tiredness.
The main purpose of this follow-up study is to see how safe mavacamten is over a longer period. The previous studies looked at how well the medicine worked and its safety over a shorter time. But doctors also need to understand any effects, both good and bad, that might only show up after many months or even years of taking a medicine.
Researchers will be carefully watching for various health events, especially those related to the heart. This includes things like heart attacks, strokes, new problems with heart rhythm, or any need for hospital treatment. They will also look at general well-being and any side effects participants might experience, as well as how the heart's function might change over time, using tests like echocardiograms (heart scans). This information is really important to make sure mavacamten can be used safely and effectively by more people in the future.
Key takeaways
- This is a long-term follow-up study for a heart medicine.
- It's for adults with hypertrophic cardiomyopathy (HCM) who were in previous mavacamten studies.
- The main goal is to carefully check the medicine's long-term safety.
- You'll have regular hospital visits for health checks and tests.
- Participation could last several years, but you can leave at any time.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. Crucially, you must have already taken part in one of two specific previous studies testing mavacamten for hypertrophic cardiomyopathy: either MAVERICK-HCM or EXPLORER-HCM.
This study is for adults of any gender who have completed one of those earlier trials. This means that if you've never been part of the MAVERICK-HCM or EXPLORER-HCM studies, you won't be able to join this particular follow-up study.
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 older?
- Do you have hypertrophic cardiomyopathy (HCM)?
- Have you previously taken part in the MAVERICK-HCM study?
- OR have you previously taken part in the EXPLORER-HCM study?
What does participation involve?
As this is a long-term follow-up study, your participation would involve regular visits to the study clinic. These visits are to allow the research team to monitor your health and the effects of the medicine. During these visits, you might have blood tests, heart scans (echocardiograms), and other checks like an ECG (a recording of your heart's electrical activity). You would continue to take Mavacamten as prescribed by the study doctors.
The aim is to track your health over an extended period, so the total duration of your participation could be quite long, potentially several years. The exact schedule of visits and tests would be explained in detail by the study team, but they are designed to be thorough while fitting into your life as much as possible.
Potential risks and benefits
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Common questions
What is hypertrophic cardiomyopathy (HCM)?
HCM is a heart condition where your heart muscle becomes thicker than normal, making it harder for your heart to pump blood effectively around your body.
What is mavacamten?
Mavacamten is a new medicine being studied to treat hypertrophic cardiomyopathy, aiming to improve heart function.
Why is this study only for people from previous trials?
This study is a continuation to see how safe mavacamten is over a very long time, so it's focused on people who have already started taking the medicine in earlier studies.
What kind of tests will I have in this study?
You might have blood tests, heart scans (echocardiograms), and ECGs to check your heart's health and how the medicine is affecting you.
Will I get paid to be in the study?
Research studies generally do not pay participants, but often reimburse for travel expenses related to study visits. This would be discussed by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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