NCT02883205

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

August 25, 2016

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Fabien Labombarda, MD

    Caen HU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien Labombarda, MD

CONTACT

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

Locations