HRMCBrS: UZ Brussel HRMC Registry of Brugada Syndrome

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Recruiting

CT.gov ID

NCT05283759

Collaborator

(none)

2,000

Enrollment

Location

480

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Brugada Syndrome	Other: No intervention because it is a patient registry

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome

Actual Study Start Date :

Jan 1, 1992

Anticipated Primary Completion Date :

Jan 1, 2032

Anticipated Study Completion Date :

Jan 1, 2032

Outcome Measures

Primary Outcome Measures

Ventricular arrhythmias [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 [through study completion, an average of 10 year]
Atrial fibrillation occurrence
Death for any cause [through study completion, an average of 10 year]
Death for any cause
Cardiovascular death [through study completion, an average of 10 year]
Death for cardiovascular cause
Genetic mutations [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Brugada syndrome diagnosis

Exclusion Criteria:

Other diagnosis different from Brugada syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel Heart Rhythm Management Center	Brussels		Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlo de Asmundis, Director of Heart Rhythm Management Center, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT05283759

Other Study ID Numbers:

UZ Brussel Brugada registry

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brugada Syndrome

Syndrome

Study Results

No Results Posted as of Mar 17, 2022