Drug-induced Brugada Syndrome Research Database

Arrhythmia Clinical Trial

Official title:

Drug-induced Brugada Syndrome Research Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048602
• Other study ID #: 07082021
• Status: Recruiting
• Start date: September 7, 2021
• Est. completion date: September 7, 2025

Study information

• Verified date: September 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Vincenzo Russo, MD PhD
• Phone: +390817062355
• Email: vincenzo.russo[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 7, 2025
• Est. primary completion date: September 7, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients with drug-induced Brugada Syndrome

Exclusion Criteria:

• Missing Informed Consent Form

• Missing Contact Informations for Follow up

Related Conditions & MeSH terms

• Arrhythmia
• Brugada Syndrome
• ICD
• Syndrome

Locations

Country	Name	City	State
Italy	Vincenzo Russo	Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudden Cardiac Death	Unexpected death due to cardiac causes that occurs in a short time period.	1 year
Primary	Appropriate ICD Therapies	Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia	1 year