DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06888271

Acronym

ANDROMEDA

Enrollment

Registered

2025-03-21

Start date

2025-05-31

Completion date

2026-07-31

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brugada Syndrome, Sudden Cardiac Death Due to Cardiac Arrhythmia

Keywords

DNA methylation, Liquid biopsy, Sudden cardiac death, Brugada syndrome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactGiuditta Benincasa, PhD

giuditta.benincasa@unicampania.it0815667916

Outcome results