Active not recruitingPHASE4INTERVENTIONAL

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

This study is investigating a new medication called mavacamten and how it might impact the heart's structure in adults diagnosed with obstructive hypertrophic cardiomyopathy. This condition causes the heart muscle to thicken, making it harder for blood to pump effectively, leading to symptoms like breathlessness or chest pain. Participants in this study have symptoms of this condition that affect their daily lives. Researchers will use special heart MRI scans to carefully look at any changes in the heart's size and shape after treatment with mavacamten. The main goal is to understand if and how mavacamten can improve the heart's structure, which could potentially lead to better management of this heart condition. This is a Phase 4 study, meaning the medicine has already been studied and approved for use.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Bristol-Myers Squibb

Enrolment target

Start

24 Jan 2024

Estimated completion

09 Jul 2026

Cardiomyopathy, Hypertrophic

What is this study about?

This research study aims to understand how a medicine called mavacamten affects the heart structure of adults living with a condition called obstructive hypertrophic cardiomyopathy (oHCM). In this condition, the heart muscle thickens, particularly a wall that separates two chambers of the heart. This thickening can make it harder for blood to leave the heart and circulate around the body, leading to symptoms such as shortness of breath, chest pain, and tiredness. Participants in this study are experiencing these symptoms, which impact their daily activities.

The study will use a very detailed type of scan called a cardiac magnetic resonance imaging (CMR) to look closely at the heart. This scan will help doctors see if mavacamten can change the heart's structure, for example, by reducing the thickness of the heart muscle or improving how blood flows through it. By closely monitoring these changes, researchers hope to gain a better understanding of how mavacamten works and its potential to improve the lives of people with oHCM.

This is a 'Phase 4' clinical trial. This means that mavacamten is already an approved treatment, and this study is being done to gather more information about its long-term effects and how it impacts the heart, adding to our knowledge of this important medication.

Key takeaways

The study investigates mavacamten's effect on heart structure in adults with obstructive hypertrophic cardiomyopathy.
Special heart MRI scans will be used to observe changes.
Participants must have symptoms that affect their daily lives.
This is a Phase 4 study, researching an already approved medication.
Participation involves taking mavacamten and attending regular clinic visits for assessments.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, adult participants must have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy, where the heart muscle thickening significantly blocks blood flow. You also need to be experiencing symptoms that affect your daily life due to this condition, such as shortness of breath or fatigue, and your heart's pumping ability (ejection fraction) should be at least 55% at rest.

There are certain reasons why you might not be able to participate. For example, if your heart thickening is due to other specific conditions, or if you have severe blockages in the arteries supplying your heart, or have recently had a life-threatening heart rhythm problem. People with certain implanted devices like pacemakers or defibrillators, or those who cannot undergo a heart MRI scan, would also not be able to join.

Additionally, there may be other specific requirements or conditions not listed here that the study doctors will discuss with you to determine if this study is suitable for your individual circumstances.

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.

Do you have a diagnosis of obstructive hypertrophic cardiomyopathy?
Are you experiencing symptoms from your heart condition that affect your day-to-day life?
Is your heart's pumping strength (ejection fraction) at least 55%?
Are you an adult aged 18 or older?
Do you have any conditions, like certain implanted devices or specific heart or lung diseases, that might prevent you from having an MRI or taking part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the medication mavacamten as prescribed by the study doctors. Throughout the study, you would have regular visits to the clinic for various assessments. These assessments will likely include detailed examinations of your heart using cardiac magnetic resonance imaging (CMR) scans, which are special MRI scans of the heart. You would also have routine medical check-ups, blood tests, and discussions about your symptoms and how you are feeling. The exact number and frequency of visits, as well as the total duration of your participation, will be clearly explained by the study team before you make a decision.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving an approved treatment, mavacamten, under close medical supervision, which could help manage your heart condition. However, as with any medication, there are potential risks and side effects associated with mavacamten that the study team will discuss in detail with you. The procedures involved, such as MRI scans and blood tests, also carry small, known risks. It's important to remember that your participation is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (23)

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

Local Institution - 0087
Verified postcode
West Hollywood, United States
Local Institution - 0003
Verified postcode
Atlanta, United States
Local Institution - 0093
Verified postcode
Boston, United States
Local Institution - 0090
Verified postcode
Cleveland, United States
Local Institution - 0086
Verified postcode
Pittsburgh, United States
Local Institution - 0017
Verified postcode
Houston, United States
Local Institution - 0035
Verified postcode
Murray, United States
Local Institution - 0076
Unverified
Ciudad Autónoma de Buenos Aires, Argentina
Local Institution - 0075
Unverified
Ciudad Autónoma de Buenos Aires, Argentina
Local Institution - 0079
Verified postcode
Pilar, Argentina
Local Institution - 0077
Verified postcode
Córdoba, Argentina
Local Institution - 0074
Verified postcode
Rosario, Argentina

Common questions

What is obstructive hypertrophic cardiomyopathy (oHCM)?

It's a heart condition where your heart muscle thickens, making it harder for blood to pump out of your heart efficiently and causing symptoms like breathlessness.

What is mavacamten?

Mavacamten is a medication that has been approved to treat obstructive hypertrophic cardiomyopathy.

What is a cardiac MRI (CMR) scan?

It's a special type of scan that uses magnets and radio waves to create detailed pictures of your heart, helping doctors see its structure and how it's working.

Why is this study being done if mavacamten is already approved?

This study aims to gather more detailed information on how mavacamten specifically affects the heart's structure over time, adding to our understanding of the treatment.

Will I have to pay to join the study?

No, you will not have to pay for the study medication or procedures if you participate in a clinical trial.