French Hypertrophic Cardiomyopathy Observatory

Hypertrophic Cardiomyopathy Clinical Trial

— REMY  

Official title:

French Hypertrophic Cardiomyopathy Observatory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01091480
• Other study ID #: 09273
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2028

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: Albert Hagege
• Phone: 33(0)156092897
• Email: albert.hagege[@]egp.ap-hop-paris.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
France	European Georges Pompidou Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (1)

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, Jeunemaître X, Empana JP, Charron P, Habib G, Réant P, Hagège A; REMY working group of the French Society of Cardiology — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival		3 years
Secondary	Diagnostic methods	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).	0 day