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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03485508
Other study ID # 2017/253
Secondary ID
Status Recruiting
Phase
First received March 26, 2018
Last updated March 26, 2018
Start date March 11, 2011
Est. completion date July 2019

Study information

Verified date February 2018
Source Universitair Ziekenhuis Brussel
Contact Esther Scheirlynck
Email esther.scheirlynck@uzbrussel.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 2019
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Transthoracic echocardiography
Transthoracic echocardiography Blood sample with assessment of biomarkers

Locations

Country Name City State
Belgium UZ Brussel Jette Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation Sudden cardiac death is death occuring within 24 hours after being seen in a healthy status or within 1 hour after initiation of symptoms. 6 years
Secondary Syncope Loss of consciousness 6 years
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