Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography
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| ClinicalTrials.gov Identifier: NCT02221141 |
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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
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Sponsor:
Laurence Gabriel
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 |
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. |
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| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| 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 | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Unknown status | ||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||