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Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221141
Recruitment Status : Unknown
Verified January 2018 by Laurence Gabriel, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur.
Recruitment status was:  Recruiting
First Posted : August 20, 2014
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Laurence Gabriel, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Tracking Information
First Submitted Date August 18, 2014
First Posted Date August 20, 2014
Last Update Posted Date February 1, 2018
Study Start Date December 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2014)
Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography
Official Title Not Provided
Brief Summary

The purpose of this study is to determine the prevalence in Belgium of Fabry disease in patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to determine in Fabry patients which was the most frequently initial symptom.

Actually the early diagnosis is important because a treatment exists that can prevent future complications.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with left ventricular hypertrophy
Condition Left Ventricular Hypertrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 19, 2014)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • unexplained left ventricular hypertrophy

Exclusion Criteria:

  • isolated septal hypertrophy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02221141
Other Study ID Numbers Fabry Disease Cardioscreening
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Laurence Gabriel, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Study Sponsor Laurence Gabriel
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Verification Date January 2018