RecruitingOBSERVATIONAL

French Hypertrophic Cardiomyopathy Observatory

This study, called the French Hypertrophic Cardiomyopathy Observatory, wants to learn more about a heart condition called hypertrophic cardiomyopathy (HCM). Despite it being a serious condition, doctors still don't have a lot of information about patients with HCM in France, including how it's diagnosed and treated. This research will gather details from patients with HCM across 50 hospitals in France. This includes information about their health when they are first diagnosed, as well as checking in with them over 18 months, three years, and five years later. The goal is to build a clearer picture of HCM in France and help improve how patients are cared for.

At a glance

Status

Recruiting

Sponsor

French Cardiology Society

Enrolment target

600

Start

01 Jan 2010

Estimated completion

01 Dec 2028

Hypertrophic Cardiomyopathy

What is this study about?

Hypertrophic cardiomyopathy (HCM) is a condition where the heart muscle becomes thickened, making it harder for the heart to pump blood effectively. Currently, doctors in France don't have enough clear information about this condition, such as how many people have it, how it's typically found, or the best ways to treat it. This lack of information makes it difficult to provide the best possible care for all patients with HCM.

This study aims to fill that gap by creating an 'observatory' – a way to gather and track information about patients with HCM across France. It will involve 50 hospitals, with a specific heart doctor at each site overseeing the collection of information. They will gather details about patients' health when they are first diagnosed, including their medical history, family health, and the results of various tests.

The study will follow patients over many years, checking in at 18 months, 3 years, and 5 years after their initial information is collected. During these follow-ups, they'll gather updates on things like the patient's general health, any new hospital stays, further tests, and changes to their treatments. By collecting all this information, researchers hope to get a much better understanding of HCM in France, which can then help improve how the condition is diagnosed and treated in the future.

Key takeaways

This study is about understanding hypertrophic cardiomyopathy (HCM) better in France.
It will collect information from patients' existing medical records over several years.
The goal is to improve diagnosis and treatment for HCM patients.
Participants will not take new medications or have extra tests for the study.
You must be at least 15 years old and have a confirmed HCM diagnosis to participate.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you need to be at least 15 years old. You must also have hypertrophic cardiomyopathy (HCM), which is confirmed by an ultrasound scan of your heart. Specifically, the main pumping chamber of your heart (the left ventricle) needs to show a wall thickness of at least 13 millimetres if someone else in your family has HCM, or at least 15 millimetres if HCM has appeared in you without any known family history.

There are a few reasons why someone might not be able to join the study. If you prefer not to participate, your wishes will be respected and you won't be included. Also, if you have another significant heart condition called aortic stenosis, where a heart valve opening is very narrow (less than 1 square centimetre), you wouldn't be eligible. This is because other conditions could make it harder to understand the results related specifically to HCM.

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 15 years old or older?
Have you been diagnosed with hypertrophic cardiomyopathy (HCM)?
Did an ultrasound scan of your heart show your left ventricle wall thickness is at least 13mm (if HCM is in your family) or 15mm (if not)?
Have you *not* been told you have severe narrowing of your aortic valve (significant aortic stenosis)?
Are you happy for your medical information to be used for this research?

Answer every question to see your result.

What does participation involve?

If you join this study, the doctors will collect information from your existing medical records from when you were first diagnosed and when you were initially in the hospital. They will also gather details about your current health, including family history and any tests you've had. You won't need to take any new or different medications specifically for this study. The researchers will then follow up with you at 18 months, 3 years, and 5 years after the initial data collection. These follow-ups will involve looking at your medical records for updates on your health, any hospital admissions, and changes to your treatments or tests. This study will primarily use information from your medical files and involve some correspondence, rather than requiring many new hospital visits or tests solely for the research. The total duration of your participation, including follow-ups, would be up to 5 years.

Potential risks and benefits

This study mainly involves collecting information from your existing medical records and through follow-up correspondence, so there are very few direct risks to you. You won't be asked to take any new medications or undergo additional procedures just for the study. The main benefit is that your information will contribute to a better understanding of hypertrophic cardiomyopathy (HCM) in France, which could lead to improved diagnosis and treatment for future patients. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

European Georges Pompidou Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is hypertrophic cardiomyopathy (HCM)?

HCM is a medical condition where your heart muscle becomes thicker than normal, making it harder for your heart to pump blood around your body.

Why is this study being done?

This study wants to learn more about HCM in France, including how it's diagnosed and treated, to help improve care for patients in the future.

Do I have to take new medicines or have extra tests?

No, this study mainly collects information from your existing medical records and follow-ups. You won't take new medicines or have extra tests just for the study.

How long will I be involved in the study?

The study will collect information initially and then check in with you at 18 months, 3 years, and 5 years, so your participation could last up to 5 years.

Can I decide not to be in the study if I change my mind?

Yes, you can choose to withdraw from the study at any point, and this will not affect the medical care you receive.

How to find out more

Albert Hagege

albert.hagege@egp.ap-hop-paris.fr 33(0)156092897 Official trial record

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