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Status unknownNCT03485508Updated Apr 2, 2018

The Brugada Syndrome: a Follow-up Study

An observational study in Brugada Syndrome, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-02.

Sponsored by Universitair Ziekenhuis Brussel · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Brugada Syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 18 years or older
  • Diagnosis of Brugada syndrome

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testTransthoracic echocardiography

    Transthoracic echocardiography Blood sample with assessment of biomarkers

    Also known as: Blood sample

05

What researchers measure

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.

    Time frame: 6 years

Secondary outcomes

  1. Syncope

    Loss of consciousness

    Time frame: 6 years

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485508
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Mar 11, 2011
Primary completion
Sep 2018 (estimated)
Completion
Jul 2019 (estimated)
Last update
Apr 2, 2018

Study contacts

Esther Scheirlynck
Contact
esther.scheirlynck@uzbrussel.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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