French Hypertrophic Cardiomyopathy Observatory

Recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT01091480
• Lead Sponsor: French Cardiology Society

Brief Summary

Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.

The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)

Detailed Description

This both retrospective and prospective study is proposed to cardiology services 50 hospitals in France. A cardiologist referral is designated for each facility.

The following data will be collected by the physician during the initial hospitalization

* Demographics

* Geographic origin of patient

* Clinical data: criteria for inclusion and non-inclusion data HCM general, Doppler ultrasound, personal history, family history

* Reviews made: non-organic, biological

* Family Survey,

* Treatments: Medical, Electrical, invasive

* Data from hospital

The follow-up to 18 months, 3 years and 5 years will be conducted by clinical-research-technicians of the French Society of Cardiology, an application will be made to municipalities of birth and mail a letter to physicians and patients.

The following data will be collected:

* Vital status

* Data from hospital

* Reviews made: non-organic, biological

* Treatments: Medical, Electrical, invasive

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age ≥ 15 years old
• Patient with HCM defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

Exclusion Criteria

• Expressed refusal to participate in the study
• Significant aortic stenosis (<1 cm ²)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Diagnostic methods	0 day	Define the profile of patients with HCM in France, diagnostic methods, evaluation (diagnostic investigation and family) and therapeutic. Who are the patients CMH France? (rules discovery, clinical presentation) and how are assumed the HCM in France? (examinations, hospitalizations, treatments, procedures for the family survey).

Trial Locations

Locations (1)

European Georges Pompidou Hospital; 🇫🇷 Paris, France