Active not recruitingOBSERVATIONAL

A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada

This study is looking back at health information from adult patients in Canada. These patients have a specific heart condition called obstructive hypertrophic cardiomyopathy (HCM) and have been taking a medicine called mavacamten (also known by its brand name, CAMZYOS). They were all part of a patient support programme, which helps people access and manage their medication. The main aim is to understand more about the people who took this medicine, such as their age and other health details, and how they used mavacamten in their everyday lives. This type of study uses existing information, rather than asking new patients to try the medicine.

At a glance

Status

Active not recruiting

Sponsor

Bristol-Myers Squibb

Enrolment target

685

Start

20 Apr 2024

Estimated completion

18 Apr 2025

Hypertrophic Cardiomyopathy

What is this study about?

This study is focused on a heart condition called hypertrophic cardiomyopathy (HCM). In HCM, the heart muscle becomes thickened, which can make it harder for the heart to pump blood around the body. Sometimes, this thickening causes an 'obstruction,' meaning it blocks the blood flow. Patients with this type of HCM often experience symptoms like breathlessness, chest pain, or feeling tired.

The study is specifically looking at patients who have been treated with a medicine called mavacamten (brand name CAMZYOS). This medicine is designed to help improve heart function in people with obstructive HCM. The information comes from a special patient support programme in Canada, set up by the company that makes mavacamten. This programme helps patients get their medication and provides support.

Researchers are using existing, de-identified information – meaning personal details that could identify someone have been removed – from patients who took part in this support programme. By looking at this real-world data, the study aims to build a picture of who these patients are, their health details, and how they used mavacamten in their regular medical care. This helps doctors and researchers understand more about how the medicine is used in practice, outside of controlled testing environments.

Key takeaways

This study uses existing health information, not new patient involvement.
It focuses on Canadian adults taking mavacamten for obstructive hypertrophic cardiomyopathy.
Data collected from a patient support programme helps understand real-world medicine use.
All personal identifying details are removed to protect patient privacy.
The study aims to learn more about patients with this heart condition and their treatment.
There are no direct risks or new treatments involved for individuals.

Who may be eligible?

To be included in this study, you must be an adult aged 18 or older. You also need to have started taking the medicine mavacamten (CAMZYOS) as part of your regular medical treatment for obstructive hypertrophic cardiomyopathy, and have been part of the patient support programme in Canada.

An important part of being included is that you must have agreed for your health information, with your personal details removed (de-identified), to be used by the researchers. This information would have been collected while you were taking part in the support programme.

There are no specific reasons that would stop someone from being included in this study, as long as they meet the points mentioned above.

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 started taking mavacamten (CAMZYOS) for obstructive hypertrophic cardiomyopathy?
Were you part of the CAMZYOS Patient Support Program in Canada?
Did you previously agree for your health information, with personal details removed, to be used for research?

Answer every question to see your result.

What does participation involve?

If you are already a patient who has been part of the CAMZYOS Patient Support Program in Canada and have taken mavacamten for obstructive hypertrophic cardiomyopathy, you wouldn't need to do anything new to 'participate' in this study. This study looks back at information that has already been collected. Researchers will use existing, de-identified health data from the support programme. This means your name and other identifying details are removed so that the researchers cannot tell who you are. You will not have any extra hospital visits, assessments, or need to take any new medication for this study. The study doesn't involve any follow-up with individual patients.

Potential risks and benefits

Since this study only looks back at existing, de-identified health information, there are no direct physical risks to participants. Your personal information will be protected, as all identifying details are removed before researchers see the data. For patients, there are no immediate personal benefits from taking part in this type of study, as no new medical care is provided. However, the information gathered can help medical professionals and researchers better understand how mavacamten is used in real life for patients with hypertrophic cardiomyopathy, potentially helping future patients. You would have already given consent for your de-identified data to be used when you joined the patient support program, but you always have the right to withdraw your consent for your data to be used in research at any time.

Locations (1)

St. Paul's Hospital
Verified postcode
Vancouver, Canada

Common questions

What is hypertrophic cardiomyopathy?

It's a condition where the heart muscle becomes unusually thick, making it harder for the heart to pump blood effectively.

What is mavacamten?

Mavacamten (CAMZYOS) is a medicine used to treat obstructive hypertrophic cardiomyopathy, helping to improve heart function.

Is this a new treatment study?

No, this study looks at information from patients who have already been taking mavacamten as part of their regular care.

Will my personal details be used?

No, all personal details are removed from your health information so that you cannot be identified by the researchers.

Do I need to do anything to be in this study?

If you meet the criteria, your de-identified health information may be used. You won't have any extra appointments or take new medicine for this study.