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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02883205
Other study ID # 15-060
Secondary ID
Status Recruiting
Phase N/A
First received August 25, 2016
Last updated August 25, 2016
Start date January 2015
Est. completion date December 2016

Study information

Verified date August 2016
Source University Hospital, Caen
Contact Fabien Labombarda, MD
Phone 611238306
Email labombarda-f@chu-caen.fr
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with left ventricular hypertrophy of unknown etiology or of sarcomeric MHC pace, followed in Normandy, has given its consent to the search of Fabry disease

Criteria Exclusion:

- Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Fabien Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of new cases of Fabry disease diagnosed a year after distribution of educational brochure cardiologists 1 year No
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