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The Brugada Syndrome: a Follow-up Study

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: NCT03485508
Recruitment Status : Unknown
Verified February 2018 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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Brief Summary:
Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.

Condition or disease Intervention/treatment
Brugada Syndrome Diagnostic Test: Transthoracic echocardiography

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study
Actual Study Start Date : March 11, 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Transthoracic echocardiography
    Transthoracic echocardiography Blood sample with assessment of biomarkers
    Other Name: Blood sample

Outcome Measures
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Primary Outcome Measures :
  1. Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation [ Time Frame: 6 years ]
    Sudden cardiac death is death occuring within 24 hours after being seen in a healthy status or within 1 hour after initiation of symptoms.


Secondary Outcome Measures :
  1. Syncope [ Time Frame: 6 years ]
    Loss of consciousness


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of Brugada syndrome

Exclusion Criteria:

  • history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485508


Contacts
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Contact: Esther Scheirlynck esther.scheirlynck@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Catherine De Greef       catherine.degreef@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03485508    
Other Study ID Numbers: 2017/253
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn