RecruitingOBSERVATIONAL

Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US

This study is gathering information about a medicine named mavacamten, used to treat adults with a heart condition called obstructive hypertrophic cardiomyopathy (oHCM). Researchers want to see how well mavacamten works in everyday medical practice in the US and what differences it makes to patients' health. They are also keen to learn directly from patients and their doctors about their experiences with this treatment. This will help them understand the real-world benefits and challenges of using mavacamten for oHCM. The study will look at past medical records and also ask patients to complete surveys.

At a glance

Status

Recruiting

Sponsor

Bristol-Myers Squibb

Enrolment target

362

Start

15 Jan 2026

Estimated completion

17 Jun 2027

Obstructive Hypertrophic Cardiomyopathy (oHCM)

What is this study about?

This study is about a heart condition called obstructive hypertrophic cardiomyopathy, or oHCM for short. In oHCM, the heart muscle becomes unusually thick, making it harder for the heart to pump blood around the body. This can cause symptoms like shortness of breath, chest pain, and tiredness.

The study is focusing on a specific medicine called mavacamten, which is used to treat oHCM. Instead of doing a traditional clinical trial where people are given a new medicine under strict conditions, this study aims to understand how mavacamten works for patients in their everyday lives, as prescribed by their doctors in the US. Researchers want to collect information from real patients and their healthcare providers to see what impact the medicine has and what their experiences are like.

The main goal is to understand if mavacamten is helping patients with oHCM feel better and improve their heart health over time. They also want to understand the challenges and positives of using this medicine from both the patient’s and doctor’s point of view. This kind of research, looking at 'real-world' experiences, helps to build a clearer picture of how treatments work outside of highly controlled study settings.

Key takeaways

Study focuses on real-world experiences with mavacamten for oHCM.
No new medication or extra clinic visits for most participants.
Aims to understand patient and doctor experiences with the treatment.
Information gathered could help improve care for future patients.
Involves reviewing existing medical records and potentially completing an online survey.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older and have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (oHCM). You also need to have been prescribed mavacamten for your oHCM by a doctor at one of the participating medical practices in the US between April 2022 and December 2024.

It's important that you haven't taken part in any previous clinical trials where you were given a heart myosin inhibitor medicine (like mavacamten) for testing. However, if you've been part of studies that only observed people without giving them new treatments, that's generally fine.

For part of the study (called Phase II), if you meet all the above conditions, you'll also need to be able to read and understand English. You would also need to have access to a computer or smartphone to complete some online questions. There are no other specific reasons that would stop you from joining, as long as you meet all the requirements mentioned.

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)?
Have you been prescribed mavacamten for your oHCM?
Have you *not* participated in any previous trials testing a heart myosin inhibitor medication?
Are you able to read and understand English (for the survey part)?
Do you have access to a computer or smartphone (for the survey part)?

Answer every question to see your result.

What does participation involve?

This study involves looking at your existing medical records from when you were treated with mavacamten (this is called a retrospective chart review). This means information about your treatment will be gathered from your past visits, so you won't need to attend any extra appointments or clinic visits specifically for this part of the study.

If you meet all the criteria and are invited to participate in the second part, you would also be asked to complete a survey. This survey would ask about your experiences with mavacamten and your heart condition. You would complete this survey on a computer or smartphone at your convenience. There is no medication given as part of this study, as it focuses on treatment you've already received. The total duration for your involvement would mainly involve the time it takes to complete the survey, if you participate in that phase.

Potential risks and benefits

This study does not involve receiving new medication or undergoing new procedures, as it looks at information from past treatments and patient experiences. Therefore, there are minimal direct physical risks. However, sharing your medical information, even if kept private, always carries a small risk. The potential benefit is that the information gathered from your experience, alongside others, can help doctors and researchers better understand how mavacamten works in the real world, potentially improving care for future patients with oHCM. You are free to withdraw your consent to participate at any time, even if you initially agreed, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Adelphi Real World
Verified postcode
Bollington, United Kingdom· Recruiting

Common questions

What is oHCM?

oHCM stands for obstructive hypertrophic cardiomyopathy. It's a condition where part of your heart muscle becomes thicker than normal, making it harder for your heart to pump blood effectively.

What is mavacamten?

Mavacamten is a medicine approved to treat obstructive hypertrophic cardiomyopathy. It helps relax the heart muscle, making it easier for the heart to pump blood.

Will I have to take new medication for this study?

No, this study is about understanding how mavacamten works in people who have already been prescribed it by their doctor. You won't be given any new medication as part of this research.

Do I need to visit a clinic for this study?

For the first part of the study, researchers will only look at your medical records. For the second part, you might be asked to complete an online survey, which you can do from home.

What information will they collect about me?

They will look at information from your medical records related to your oHCM and mavacamten treatment. If you do the survey, they'll ask about your experiences and how you feel about the treatment.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.