French Hypertrophic Cardiomyopathy Observatory
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Event-free survival [Time frame: 3 years]
Secondary outcome measures (1)
- Diagnostic methods [Time frame: 0 day]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- European Georges Pompidou Hospital — Paris
Publications
- 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 PMID 30316646
- Sakhi H, Soulat G, Craiem D, Gencer U, Lamy J, Stipechi V, Puscas T, Hulot JS, Hagege A, Mousseaux E. Association of Impaired Left Ventricular Mitral Filling from 4D Flow Cardiac MRI and Prognosis of Hypertrophic Cardiomyopathy. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230198. doi: 10.1148/ryct.230198. PMID 38512023
Identifiers
NCT: NCT01091480 · 09273