Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist
TARIFF
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 30, 2016
August 1, 2016
1.9 years
August 25, 2016
August 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of new cases of Fabry disease diagnosed a year after distribution of educational brochure cardiologists
1 year
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fabien
Caen, 14033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabien Labombarda, MD
Caen HU
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2016
First Posted
August 30, 2016
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 30, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share