UZ Brussel HRMC Registry of Brugada Syndrome (HRMCBrS)

March 12, 2022 updated by: Carlo de Asmundis, Universitair Ziekenhuis Brussel

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.

These includes:

  1. demographical data: age, sex
  2. antropometric data: height, weight, BMI
  3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy

3) 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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Recruiting
        • UZ Brussel Heart Rhythm Management Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Brugada syndrome diagnosis

Exclusion Criteria:

  • Other diagnosis different from Brugada syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 10 year
Atrial fibrillation
Time Frame: through study completion, an average of 10 year
Atrial fibrillation occurrence
through study completion, an average of 10 year
Death for any cause
Time Frame: through study completion, an average of 10 year
Death for any cause
through study completion, an average of 10 year
Cardiovascular death
Time Frame: through study completion, an average of 10 year
Death for cardiovascular cause
through study completion, an average of 10 year
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1992

Primary Completion (Anticipated)

January 1, 2032

Study Completion (Anticipated)

January 1, 2032

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZ Brussel Brugada registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brugada Syndrome

Clinical Trials on No intervention because it is a patient registry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe