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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT01198899
• Collaborator: (none)
• Enrollment: 540
• Locations: 9
• Duration (Months): 25
• Patients Per Site: 60
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	Phase
Left Ventricular Hypertrophy	Other: blood sampling

Study Design

• 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: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography [At baseline T0]

   patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AZ Imelda	Bonheiden		Belgium
2	AZ Sint-Blasius	Dendermonde		Belgium
3	AZ Sint-Lucas	Gent		Belgium
4	Maria Middelares	Gent		Belgium
5	University Hospital Ghent	Ghent		Belgium
6	Jan Yperman Ziekenhuis	Ieper		Belgium
7	AZ Oostkust	Knokke-Heist		Belgium
8	ZOL	Limburg		Belgium
9	AZ Zusters van Barmhartigheid	Ronse		Belgium

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• website of University Hospital Ghent, Belgium

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT01198899
• Other Study ID Numbers: 2009/035
• First Posted: Sep 10, 2010
• Last Update Posted: Jan 12, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by University Hospital, Ghent: Fabry-Anderson disease; gen mutation; left ventricular hypertrophy
• Additional relevant MeSH terms: Fabry Disease; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy, Left Ventricular; Hypertrophy

Study Results

No Results Posted as of Jan 12, 2012