Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01198899
First received: August 31, 2010
Last updated: January 11, 2012
Last verified: January 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Left Ventricular Hypertrophy |
Other: blood sampling |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
chylomicron retention disease
Fabry disease
familial hypertrophic cardiomyopathy
Farber lipogranulomatosis
Schindler disease
succinic semialdehyde dehydrogenase deficiency
supravalvular aortic stenosis
MedlinePlus related topics:
Cardiomyopathy
U.S. FDA Resources
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography [ Time Frame: At baseline T0 ] [ Designated as safety issue: No ]patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months
| Enrollment: | 540 |
| Study Start Date: | July 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
left ventricular hypertrophy
Patients with left ventricular hypertrophy will be used.
|
Other: blood sampling
Blood sampling will be used.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with left ventricular hypertrophy
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198899
Locations
| Belgium | |
| AZ Imelda | |
| Bonheiden, Belgium | |
| AZ Sint-Blasius | |
| Dendermonde, Belgium | |
| Maria Middelares | |
| Gent, Belgium | |
| AZ Sint-Lucas | |
| 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, Belgium | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Raymond Vanholder, MD, PhD | University Hospital Ghent, Belgium |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01198899 History of Changes |
| Other Study ID Numbers: | 2009/035 |
| Study First Received: | August 31, 2010 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
Fabry-Anderson disease gen mutation left ventricular hypertrophy |
Additional relevant MeSH terms:
|
Fabry Disease Cardiomyopathy, Hypertrophic Hypertrophy Hypertrophy, Left Ventricular Cardiomyopathies Sphingolipidoses Lysosomal Storage Diseases, Nervous System Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn |
Metabolism, Inborn Errors Lipidoses Lipid Metabolism, Inborn Errors Lysosomal Storage Diseases Metabolic Diseases Lipid Metabolism Disorders Heart Diseases Cardiovascular Diseases Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases Pathological Conditions, Anatomical Cardiomegaly |
ClinicalTrials.gov processed this record on May 19, 2013