MEMENTO-A Phase 3b/4 Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to assess the impact on Myocardial Structure with Cardiac Magnetic Resonance Imaging (CMR)
This study is investigating a new medicine, mavacamten, for adults who have a heart condition called obstructive hypertrophic cardiomyopathy (HCM). In HCM, the heart muscle becomes unusually thick, making it harder for the heart to pump blood effectively. This study wants to find out if mavacamten can help reduce the thickness of the heart walls and the size of the upper chambers of the heart. Researchers will use special heart scans (Cardiac Magnetic Resonance Imaging) to measure these changes after about a year. The study will also check if the medicine improves how people feel and function in their daily lives, and if it's safe to use.
At a glance
What is this study about?
This research study is about a heart condition called obstructive hypertrophic cardiomyopathy (oHCM). In this condition, the heart muscle, particularly the main pumping chamber, becomes thicker than normal. This extra thickness can block blood flow from the heart to the rest of the body, causing symptoms like shortness of breath, chest pain, and tiredness.
The study aims to test a new medicine called mavacamten. Researchers want to see if this medicine can help by making the thickened heart walls thinner and reducing the size of the upper chambers of the heart. They will use special heart scans, called Cardiac Magnetic Resonance Imaging (CMR), to measure these changes accurately over approximately a year.
Beyond just looking at heart size and thickness, the study also wants to understand if mavacamten helps people feel better. They will check if it improves how well people can do their daily activities without feeling too tired or out of breath. Safety is also very important, so the study will keep a close eye on any side effects or other heart-related events that might happen.
Key takeaways
- This study tests a new medicine, mavacamten, for a heart condition called oHCM.
- It aims to see if the medicine shrinks thickened heart walls and improves symptoms.
- Participants will take either mavacamten or a dummy pill (placebo).
- Heart scans (CMR) will be used to check changes in heart structure.
- The study lasts for about 48 weeks and includes regular clinic visits.
- Participation could help future understanding and treatment of oHCM.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This means you have the heart condition and are experiencing symptoms related to it, like shortness of breath or chest pain.
Both men and women can take part in this research. Before joining, the study team will ask you some questions and do some checks to make sure the study is a safe and suitable option for you.
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?
- Have you been diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)?
- Are you currently experiencing symptoms from your oHCM?
- Are you able to attend regular clinic visits and have heart scans?
What does participation involve?
If you decide to take part in this study, you would receive either the study medicine, mavacamten, or a placebo (a dummy pill that looks like the active medicine but contains no active drug). You wouldn't know which one you are taking, nor would your study doctor. This is to ensure the results are as fair as possible. You would take the medicine in capsule form.
Over the course of about a year, you would have regular visits to the study clinic. These visits would include physical examinations, blood tests, and heart scans (Cardiac Magnetic Resonance Imaging, or CMR) to see how your heart is responding. The study team will guide you through all required assessments and visits. The total duration of your participation in the study would be approximately 48 weeks, or just under a year.
Potential risks and benefits
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Common questions
What is obstructive hypertrophic cardiomyopathy (oHCM)?
It's a heart condition where the heart muscle becomes abnormally thick, often making it harder for blood to leave the heart.
What is mavacamten?
Mavacamten is a new medicine being tested to see if it can help reduce the thickness of the heart muscle in people with oHCM.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active drug. It helps compare how effective the real medicine is.
What is a heart scan (CMR)?
CMR stands for Cardiac Magnetic Resonance Imaging. It's a special type of scan that takes detailed pictures of your heart to see its structure and how it's working.
How long will the study last?
Your participation in the study is expected to last for about 48 weeks, which is just under a year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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