Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-06 @ 12:25 PM
Study NCT ID:
NCT02883205
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of new cases of Fabry disease diagnosed a year after distribution of educational brochure cardiologists', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiomyopathies']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nCriteria Exclusion:\n\n* Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease'}, 'identificationModule': {'nctId': 'NCT02883205', 'acronym': 'TARIFF', 'briefTitle': 'Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist', 'orgStudyIdInfo': {'id': '15-060'}}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien Labombarda, MD', 'role': 'CONTACT', 'email': 'labombarda-f@chu-caen.fr', 'phone': '231064418'}], 'facility': 'Fabien', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Fabien Labombarda, MD', 'role': 'CONTACT', 'email': 'labombarda-f@chu-caen.fr', 'phone': '611238306'}], 'overallOfficials': [{'name': 'Fabien Labombarda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caen HU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}