Brugada SyndromeNCT03485508
The Brugada Syndrome: a Follow-up Study
An observational study of Brugada Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Transthoracic echocardiography
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Mar 2011to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.
Who may be able to join
- 18 years or older
- Diagnosis of Brugada syndrome
Who cannot join
- history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy
Trial locations and contacts
1 site in 1 country.
Esther Scheirlynck contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Catherine De Greef, catherine.degreef@uzbrussel.be
About this study
Official title: Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study
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.
- Conditions
- Brugada Syndrome
- Being tested
- Transthoracic echocardiography
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Also called Blood sample
Transthoracic echocardiography Blood sample with assessment of biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Secondary outcomes (1)
Syncope
Loss of consciousness
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start11 Mar 2011
- Primary completionSep 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485508
- Sponsor's protocol ID
- 2017/253
- Status last verified
- Feb 2018
- First submitted
- 26 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study
- ClinicalTrials.gov ID
- NCT03485508
- Acronym / sponsor ID
- 2017/253
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 11 Mar 2011 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.
Key inclusion criteria (2 listed)
- 18 years or older
- Diagnosis of Brugada syndrome
Key exclusion criteria (1 listed)
- history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyAlso: Blood sampleTransthoracic echocardiography Blood sample with assessment of biomarkers | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Syncope
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Scheirlynck contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Scheirlynck (esther.scheirlynck@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.