NCT05048602

Brief Summary

All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 7, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2025

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 8, 2021

Last Update Submit

September 8, 2021

Conditions

Brugada SyndromeArrhythmiaICD

Outcome Measures

Primary Outcomes (2)

  • Sudden Cardiac Death

    Unexpected death due to cardiac causes that occurs in a short time period.

    1 year

  • Appropriate ICD Therapies

    Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia

    1 year

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with drug-induced Brudaga Syndrome

You may qualify if:

  • All consecutive patients with drug-induced Brugada Syndrome

You may not qualify if:

  • Missing Informed Consent Form
  • Missing Contact Informations for Follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vincenzo Russo

Naples, Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Brugada SyndromeArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincenzo Russo, MD PhD

    University of Campania Luigi Vanvitelli

    STUDY CHAIR

Central Study Contacts

Vincenzo Russo, MD PhD

CONTACT

+390817062355vincenzo.russo@unicampania.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

September 7, 2021

Primary Completion

September 7, 2023

Study Completion

September 7, 2025

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

IT(1)