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NCT01198899 Clinical Trial

Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy

Left Ventricular Hypertrophy Clinical Trial

Official title:
Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01198899
Other study ID # 2009/035
Secondary ID
Status Completed
Phase N/A
First received August 31, 2010
Last updated January 11, 2012
Start date July 2009
Est. completion date August 2011

Study information
Verified date January 2012
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study is a screening study

Recruitment information / eligibility
Status Completed
Enrollment 540
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients over 18 years undergoing a routine echocardiography in the participating hospitals

- Both genders will be considered.

- Patients can be included if on 2D echocardiography the maximal septal wall thickness > 13 mm and/or the posterior wall thickness > 13 mm. The limit for inclusion is kept relatively low to detect early forms of Fabry cardiomyopathy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• blood sampling
Blood sampling will be used.

Locations
Country Name City State
Belgium AZ Imelda Bonheiden
Belgium AZ Sint-Blasius Dendermonde
Belgium AZ Sint-Lucas Gent
Belgium Maria Middelares Gent
Belgium University Hospital Ghent Ghent
Belgium Jan Yperman Ziekenhuis Ieper
Belgium AZ Oostkust Knokke-Heist
Belgium ZOL Limburg
Belgium AZ Zusters van Barmhartigheid Ronse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months At baseline T0 No
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