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

January 11, 2012 updated by: University Hospital, Ghent
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • AZ Imelda
      • Dendermonde, Belgium
        • AZ Sint-Blasius
      • Gent, Belgium
        • AZ Sint-Lucas
      • Gent, Belgium
        • Maria Middelares
      • Ghent, Belgium
        • University Hospital Ghent
      • Ieper, Belgium
        • JAN YPERMAN Ziekenhuis
      • Knokke-Heist, Belgium
        • AZ Oostkust
      • Limburg, Belgium
        • ZOL
      • Ronse, Belgium
        • AZ Zusters Van Barmhartigheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with left ventricular hypertrophy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital Ghent, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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