French Hypertrophic Cardiomyopathy Observatory

NCT ID: NCT01091480

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with HCM

Patients ≥ 15 years 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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Hagege Albert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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European Georges Pompidou Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Albert Hagege

Role: CONTACT

33(0)156092897

Facility Contacts

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Albert Hagege

Role: primary

33(0)156093683

References

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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.

Reference Type RESULT
PMID: 30316646 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38512023 (View on PubMed)

Other Identifiers

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09273

Identifier Type: -

Identifier Source: org_study_id

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