Brugada SyndromeHRMCBrSNCT05283759
UZ Brussel HRMC Registry of Brugada Syndrome
An observational study of Brugada Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brugada Syndrome
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 1992to 1 Jan 2032
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Brugada syndrome patients diagnosed following current guidelines: (Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793-2867.) Both Brugada spontaneous type 1 and ajmaline induced will be included.
Who may be able to join
- Brugada syndrome diagnosis
Who cannot join
- Other diagnosis different from Brugada syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel Heart Rhythm Management Center
Brussels, 1090
Carlo de Asmundis, MD, PhD, +32024763704, hrmc@uzbrussel.be
About this study
Official title: UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).
Read the detailed description
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.
These includes:
- demographical data: age, sex
- antropometric data: height, weight, BMI
- clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy
- data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation
- Conditions
- Brugada Syndrome
- Being tested
- No intervention because it is a patient registry
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention because it is a patient registryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmias
Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy
Measured: through study completion, an average of 10 year
Atrial fibrillation
Atrial fibrillation occurrence
Measured: through study completion, an average of 10 year
Death for any cause
Death for any cause
Measured: through study completion, an average of 10 year
Cardiovascular death
Death for cardiovascular cause
Measured: through study completion, an average of 10 year
Genetic mutations
Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jan 1992
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo de Asmundis, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283759
- Sponsor's protocol ID
- UZ Brussel Brugada registry
- Acronym
- HRMCBrS
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome
- ClinicalTrials.gov ID
- NCT05283759
- Acronym / sponsor ID
- HRMCBrS / UZ Brussel Brugada registry
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 1992 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 17 Mar 2022 (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.
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).
Detailed description
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.
These includes:
- demographical data: age, sex
- antropometric data: height, weight, BMI
- clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy
- data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brugada syndrome patients diagnosed following current guidelines: (Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793-2867.) Both Brugada spontaneous type 1 and ajmaline induced will be included.
Key inclusion criteria (1 listed)
- Brugada syndrome diagnosis
Key exclusion criteria (1 listed)
- Other diagnosis different from Brugada syndrome
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 |
|---|---|---|
| No intervention because it is a patient registry | Other | – |
Primary outcome
Ventricular arrhythmias
Time frame: through study completion, an average of 10 year
Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy
Atrial fibrillation
Time frame: through study completion, an average of 10 year
Atrial fibrillation occurrence
Death for any cause
Time frame: through study completion, an average of 10 year
Death for any cause
Cardiovascular death
Time frame: through study completion, an average of 10 year
Death for cardiovascular cause
Genetic mutations
Time frame: Baseline
Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No. No IPD sharing
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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.
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 1 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: looking for participants now, as of the sponsor's last update on 17 Mar 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo de Asmundis, MD, PhD (+32024763704, hrmc@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmias (time frame: through study completion, an average of 10 year). The study lists 5 primary outcomes in all. 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 17 Mar 2022.