- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091480
French Hypertrophic Cardiomyopathy Observatory (REMY)
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)
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Albert Hagege
- Phone Number: 33(0)156092897
- Email: albert.hagege@egp.ap-hop-paris.fr
Study Locations
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Paris, France, 75015
- Recruiting
- European Georges Pompidou Hospital
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Contact:
- Albert Hagege
- Phone Number: 33(0)156093683
- Email: albert.hagege@egp.ap-hop-paris.fr
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Principal Investigator:
- Albert Hagege
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event-free survival
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic methods
Time Frame: 0 day
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
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