DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

Not yet recruiting

• Conditions: Brugada Syndrome; Sudden Cardiac Death Due to Cardiac Arrhythmia

• Registration Number: NCT06888271
• Lead Sponsor: University of Campania Luigi Vanvitelli

Brief Summary

The goal of this observational study is to evaluate if there are differences in DNA methylation of peripheral blood in patients with Brugada syndrome and healthy subjects. The main question it aims to answer is:

Does DNA methylation changes distinguish Brugada patients from healthy controls?

Does DNA methylation changes distinguish Brugada patients with high versus low risk of sudden cardiac death?

Detailed Description

The Investigators will enroll 10 patients with Brugada syndrome and 10 age and sex matched healthy controls. We will collect 5 mL of peripheral blood and will analyze genome-wide DNA methylation via EPIC array platform. Bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-24
• Study Start: 2025-05
• Primary Completion: 2026-02
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Brugada syndrome was confirmed when the 12-lead ECG showed ST-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a Class I antiarrhythmic) in the absence of any structural heart disease.
• >18 years
• Unrelated patients

Exclusion Criteria

• Related patients
• Not type 1 Br patter

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of differentially methylated genes as assessed by EPIC microarray	3 months	We will compare the methylation profiles of patients and controls in order to obtain a panel of differentially methylated genes.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death	6 months	We will perform a subgroup analysis of Brugada patients (high vs. low risk of sudden cardiac death). ROC curve analysis will be performed to identify which differentially methylated genese may be useful to predict the risk of sudden cardiac death.