BMS CV027-031, A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
This study is investigating a new medicine called Mavacamten for adults who have a specific heart condition known as non-obstructive hypertrophic cardiomyopathy. This condition means the heart muscle is thickened, but it doesn't block blood flow as much as another type. The main goal is to find out if Mavacamten can improve how people feel in their daily lives, using a special questionnaire, and how well they can exercise after about a year (48 weeks). Participants will receive either the active medicine or a placebo (a dummy pill) without knowing which one they have. This helps researchers understand the true effects of the new treatment.
At a glance
What is this study about?
This research study is focused on a heart condition called non-obstructive hypertrophic cardiomyopathy. In simple terms, this is when the heart's main pumping chamber (the left ventricle) has thicker walls than normal, making it harder for the heart to relax and fill with blood. Unlike other types, the thickened muscle doesn't create a major blockage to blood flow out of the heart.
The study is testing a new medicine called Mavacamten. Researchers want to see if this medicine can help adults with this specific heart condition feel better and improve their overall quality of life. They are particularly interested in whether it helps with symptoms such as shortness of breath or tiredness, and if it improves how well people can do physical activities.
To find this out, some participants will receive Mavacamten, and others will receive a placebo – a pill that looks exactly the same but contains no active medicine. Neither the participants nor their doctors will know who is getting which. This is a common and important way to ensure the results are accurate and not influenced by what people expect. The study will look at changes over 48 weeks (just under a year) to understand the long-term effects.
Key takeaways
- Tests a new medicine, Mavacamten, for a specific heart condition.
- Aims to improve symptoms and exercise ability over 48 weeks.
- Compares the new medicine against a 'dummy pill' (placebo).
- Open to adults aged 18 and older with non-obstructive hypertrophic cardiomyopathy.
- Involves regular clinic visits and health assessments.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adult men and women, meaning anyone aged 18 years or older. There is no upper age limit specified, so older adults can also be considered.
The main requirement is that you must have been diagnosed with non-obstructive hypertrophic cardiomyopathy and be experiencing symptoms related to this condition.
There will be other detailed medical checks to make sure the study is safe and appropriate for you, but these are the main starting points for anyone considering taking part.
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 non-obstructive hypertrophic cardiomyopathy?
- Are you currently experiencing symptoms from your heart condition?
- Are you able to take capsules by mouth?
- Are you able to attend regular clinic appointments for almost a year?
What does participation involve?
If you decide to take part, you would be assigned to either receive the new medicine, Mavacamten, or a placebo (a dummy pill). You wouldn't know which one you are taking. You would need to take the capsules as instructed for 48 weeks, which is almost one year.
Throughout this period, you would have regular visits to the clinic for various assessments. These assessments would likely include questionnaires about how you are feeling (like the KCCQ CSS), tests to measure your exercise ability (like pVO2 tests), blood tests, and potentially heart scans or other checks to monitor your heart health. The total duration of active participation in the study, including all treatments and check-ups, would be 48 weeks, followed by any necessary final evaluations.
Potential risks and benefits
Locations (13)
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Common questions
What is non-obstructive hypertrophic cardiomyopathy?
It's a heart condition where the heart muscle is thicker than usual, making it harder for the heart to relax and fill normally, but without a major blockage to blood flow.
What is Mavacamten?
It's a new medicine being tested to see if it can help improve symptoms and exercise ability in people with this heart condition.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medicine but contains no active ingredients. It helps researchers understand if the real medicine is truly effective.
How long does the study last?
The main treatment and observation period for the study is 48 weeks, which is nearly one year.
What will I have to do if I join?
You'll take study capsules daily and attend regular hospital visits for check-ups, questionnaires, exercise tests, and blood tests.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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