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Drug-induced Brugada Syndrome Research Database

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Recruiting
CT.gov ID
NCT05048602
Collaborator
(none)
500
Enrollment
1
Location
48
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Drug-induced Brugada Syndrome Research Database
    Actual Study Start Date :
    Sep 7, 2021
    Anticipated Primary Completion Date :
    Sep 7, 2023
    Anticipated Study Completion Date :
    Sep 7, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Sudden Cardiac Death [1 year]

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

    2. Appropriate ICD Therapies [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All consecutive patients with drug-induced Brugada Syndrome
    Exclusion Criteria:

    • Missing Informed Consent Form

    • Missing Contact Informations for Follow up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vincenzo Russo Naples Napoli Italy 80131

    Sponsors and Collaborators

    • University of Campania "Luigi Vanvitelli"

    Investigators

    • Study Chair: Vincenzo Russo, MD PhD, University of Campania "Luigi Vanvitelli"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vincenzo Russo, Principal Investigator, University of Campania "Luigi Vanvitelli"
    ClinicalTrials.gov Identifier:
    NCT05048602
    Other Study ID Numbers:
    • 07082021
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brugada Syndrome
    Syndrome

    Study Results

    No Results Posted as of Sep 17, 2021