DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

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?

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Key information

Conditions

Brugada Syndrome Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Genetic Diseases, Inborn Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Due to Cardiac Arrhythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of differentially methylated genes as assessed by EPIC microarray

Time frame: 3 months

We will compare the methylation profiles of patients and controls in order to obtain a panel of differentially methylated genes.

Secondary outcomes

Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuditta Benincasa, PhD

CONTACT

[email protected]

0815667916

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)

Acronym: ANDROMEDA

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 21, 2025
Registry last updated: Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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