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NCT05274646 Clinical Trial

Impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A

Arrhythmias, Cardiac Clinical Trial

— RISKOVER  

Official title:
Impact on Risk Stratification of Overlap Syndrome Phenotype (Brugada and Long QT Type 3) in Patients With E1784K Mutation in SCN5A

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05274646
Other study ID # 2021/CHU/36
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2022
Est. completion date August 4, 2024

Study information
Verified date September 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact Maxime CHURET, MD
Phone +262(0)262359153
Email maxime.churet@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In patients expressing the SCN5A-E1784K mutation (Glu1784Lys), cardiovascular risk is difficult to define as the stratification of these patients is challenging. From our experience, major cardiovascular events (MCE) tend to occur more frequently in patients expressing overlap syndrome phenotype (Brugada syndrome and Long QT syndrome type 3)than in patients expressing a single phenotype (whether Brugada syndrome or Long QT syndrome type 3). This trials is led on the impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A ( RISKOVER )

Description:

Study design: This study will compare the occurrence of MCE between patients with overlap syndrome phenotype and patients with a single phenotype (whether Brugada syndrome or Long QT syndrome type 3) in a cohort of patients 12 years of age and older with the SCN5A-E1784K mutation. Eligible patients will be identified nationwide and included retrospectively and prospectively. Occurrence of MCE between the group " overlap syndrome " and the group " single phenotype " will be compared.

Recruitment information / eligibility
Status Recruiting
Enrollment 64
Est. completion date August 4, 2024
Est. primary completion date August 4, 2024
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - genotype E1784K (glu1784lys) in SCN5A gene Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Réunion CHU de La Réunion Saint-Pierre France

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of MCE occurrence of syncop, sudden cardiac death, ventricular arrhythmia, cardiopulmonary arrest collected by a series of medical questions at inclusion
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