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

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ClinicalTrials.gov Identifier: NCT01198899
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief 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

Condition or disease Intervention/treatment
Left Ventricular Hypertrophy Other: blood sampling

Study Type : Observational
Actual Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011


Group/Cohort Intervention/treatment
left ventricular hypertrophy
Patients with left ventricular hypertrophy will be used.
Other: blood sampling
Blood sampling will be used.




Primary Outcome Measures :
  1. 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 ]
    patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198899


Locations
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, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital Ghent, Belgium

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01198899     History of Changes
Other Study ID Numbers: 2009/035
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by University Hospital, Ghent:
Fabry-Anderson disease
gen mutation
left ventricular hypertrophy

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Fabry Disease
Cardiomyopathy, Hypertrophic
Hypertrophy, Left Ventricular
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Vascular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly