NCT03485508

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 11, 2011

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 2, 2018

Status Verified

February 1, 2018

Enrollment Period

7.5 years

First QC Date

March 26, 2018

Last Update Submit

March 26, 2018

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Syncope

    6 years

Interventions

Transthoracic echocardiographyDIAGNOSTIC_TEST

Transthoracic echocardiography Blood sample with assessment of biomarkers

Also known as: Blood sample

Eligibility Criteria

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

Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.

You may qualify if:

  • years or older
  • Diagnosis of Brugada syndrome

You may not qualify if:

  • history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Brugada Syndrome

Interventions

EchocardiographyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Esther Scheirlynck

CONTACT

esther.scheirlynck@uzbrussel.be

Study Design

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

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

March 11, 2011

Primary Completion

September 1, 2018

Study Completion

July 1, 2019

Last Updated

April 2, 2018

Record last verified: 2018-02

Locations

BE(1)