NCT01198899

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

2.1 years

First QC Date

August 31, 2010

Last Update Submit

January 11, 2012

Conditions

Keywords

Fabry-Anderson diseasegen mutationleft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

left ventricular hypertrophy

Patients with left ventricular hypertrophy will be used.

Other: blood sampling

Interventions

Blood sampling will be used.

left ventricular hypertrophy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with left ventricular hypertrophy

You may qualify if:

  • All patients over 18 years undergoing a routine echocardiography in the participating hospitals
  • Both genders will be considered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

AZ Imelda

Bonheiden, Belgium

Location

AZ Sint-Blasius

Dendermonde, Belgium

Location

AZ Sint-Lucas

Ghent, Belgium

Location

Maria Middelares

Ghent, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Jan Yperman Ziekenhuis

Ieper, Belgium

Location

AZ Oostkust

Knokke-Heist, Belgium

Location

ZOL

Limbourg, Belgium

Location

AZ Zusters van Barmhartigheid

Ronse, Belgium

Location

Related Publications (1)

  • Terryn W, Deschoenmakere G, De Keyser J, Meersseman W, Van Biesen W, Wuyts B, Hemelsoet D, Pascale H, De Backer J, De Paepe A, Poppe B, Vanholder R. Prevalence of Fabry disease in a predominantly hypertensive population with left ventricular hypertrophy. Int J Cardiol. 2013 Sep 10;167(6):2555-60. doi: 10.1016/j.ijcard.2012.06.069. Epub 2012 Jul 16.

Related Links

MeSH Terms

Conditions

Hypertrophy, Left VentricularFabry Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Raymond Vanholder, MD, PhD

    University Hospital Ghent, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 10, 2010

Study Start

July 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations