Drug-induced Brugada Syndrome Research Database | NCT05048602

Studies
Drug-induced Brugada Syndrome Research Database

NCT05048602

Sponsor

University of Campania Luigi Vanvitelli

Status

Unknown status

Last Update Posted

Sep 17, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Brugada Syndrome
Arrhythmia
ICD

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2021Actual

Primary Completion Date

Sep 7, 2023Estimated

Completion Date

Sep 7, 2025Estimated

First Submitted Date

Sep 8, 2021

First Submission Date that Met QC Criteria

Sep 8, 2021

First Posted Date

Sep 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2021

Last Update Posted Date

Sep 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincenzo Russo, Principal Investigator, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consecutive patients with drug-induced Brugada Syndrome

Exclusion Criteria:

Missing Informed Consent Form
Missing Contact Informations for Follow up

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with drug-induced Brudaga Syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincenzo Russo, MD PhD	Contact	+390817062355		vincenzo.russo@unicampania.it

Overall Officials

Name	Affiliation	Role
Vincenzo Russo, MD PhD	University of Campania Luigi Vanvitelli	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vincenzo Russo	Recruiting	Naples	Napoli	80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D053840	Brugada Syndrome
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease
D030342	Genetic Diseases, Inborn

Browse Leaves

Not provided

Browse Branches

Not provided