Clinical trial NCT01091480: French Hypertrophic Cardiomyopathy Observatory
Official title: French Hypertrophic Cardiomyopathy Observatory
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic cardiomyopathy
Observatory
LVH
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 15 years old with HCM (sarcomere of origin or not) defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

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

Eligibility criteria: 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)

Primary outcomes:
measure: Event-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Diagnostic methods
timeFrame: 0 day
Other outcomes:
Locations:
city: Paris
country: France
facility: European Georges Pompidou Hospital
Study officials:
References:
citation: Mirabel M, Damy T, Donal E, Huttin O, Labombarda F, Eicher JC, Cervino C, Laurito M, Offredo L, Tafflet M, Jouven X, Giura G, Desnos M, Jeunemaitre X, Empana JP, Charron P, Habib G, Reant P, Hagege A; REMY working group of the French Society of Cardiology. Influence of centre expertise on the diagnosis and management of hypertrophic cardiomyopathy: A study from the French register of hypertrophic cardiomyopathy (REMY). Int J Cardiol. 2019 Jan 15;275:107-113. doi: 10.1016/j.ijcard.2018.09.083. Epub 2018 Sep 28.