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French Hypertrophic Cardiomyopathy Observatory (REMY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01091480
Recruitment Status : Recruiting
First Posted : March 24, 2010
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
Hagege Albert, 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)

Condition or disease
Hypertrophic Cardiomyopathy

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

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: French Hypertrophic Cardiomyopathy Observatory
Actual Study Start Date : January 2010
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2028

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

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Diagnostic methods [ Time Frame: 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).

Biospecimen Retention:   Samples With DNA
Systematic search for predisposition genes and Fabry disease in patients with hypertrophic cardiomyopathy (GE-REMY) with blood sampling at baseline or during a consultation normally scheduled as part of the management of this pathology

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091480

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Contact: Albert Hagege 33(0)156092897

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European Georges Pompidou Hospital Recruiting
Paris, France, 75015
Contact: Albert Hagege    33(0)156093683   
Principal Investigator: Albert Hagege         
Sponsors and Collaborators
French Cardiology Society
Publications of Results:
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Responsible Party: Hagege Albert, Professor, French Cardiology Society Identifier: NCT01091480    
Other Study ID Numbers: 09273
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Hagege Albert, French Cardiology Society:
Hypertrophic cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases