DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

NCT06888271 | Not Yet Recruiting

• 2 other identifiers: Vanvitelli-Benincasa GPE00000015
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Brugada Syndrome; Sudden Cardiac Death Due to Cardiac Arrhythmia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of differentially methylated genes as assessed by EPIC microarray

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

  3 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Healthy subjects

The control group consisted of unrelated age- and sex-matched healthy subjects as volunteer blood donors with no evidence of any ECG abnormalities, inherited arrhythmia, genetic cardiomyopathy, and no history of ventricular arrhythmia, unexplained syncope, unexplained sudden cardiac arrest/ death.

Brugada patients

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Brugada syndrome attended the Cardiology Dept. at University of Campania "L. Vanvitelli", Monaldi Hospital (Naples, Italy). The control group consisted of unrelated age- and sex-matched healthy subjects as volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale at University of Campania "L. Vanvitelli" (Naples, Italy).

You may qualify if:

• 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

You may not qualify if:

• Related patients
• Not type 1 Br patter

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (1)

• Benincasa G, Pepin ME, Russo V, Cacciatore F, D'Alto M, Argiento P, Romeo E, Chiappetti R, Laezza N, Wende AR, Schiattarella GG, Coscioni E, La Montagna A, Amarelli C, Maiello C, Golino P, Condorelli G, Napoli C. High-resolution DNA methylation changes reveal biomarkers of heart failure with preserved ejection fraction versus reduced ejection fraction. Basic Res Cardiol. 2025 Apr;120(2):347-361. doi: 10.1007/s00395-024-01093-7. Epub 2024 Dec 27.

  PMID: 39725721 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Brugada Syndrome; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Giuditta Benincasa, PhD

CONTACT

0815667916; giuditta.benincasa@unicampania.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03