NCT05283759

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Jan 1992

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 1992Jan 2032

Study Start

First participant enrolled

January 1, 1992

Completed
30.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

40 years

First QC Date

February 23, 2022

Last Update Submit

March 12, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Ventricular arrhythmias

    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

    Atrial fibrillation occurrence

    through study completion, an average of 10 year

  • Death for any cause

    Death for any cause

    through study completion, an average of 10 year

  • Cardiovascular death

    Death for cardiovascular cause

    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.

    Baseline

Interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Brugada syndrome diagnosis

You may not qualify if:

  • Other diagnosis different from Brugada syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel Heart Rhythm Management Center

Brussels, 1090, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA analysis

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Carlo de Asmundis, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Heart Rhythm Management Center

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 17, 2022

Study Start

January 1, 1992

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No IPD sharing

Locations