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

U

University of Campania Luigi Vanvitelli

Status

Not yet enrolling

Conditions

Sudden Cardiac Death Due to Cardiac Arrhythmia
Brugada Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT06888271
PE00000015 (Other Grant/Funding Number)
Vanvitelli-Benincasa G

Details and patient eligibility

About

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?

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Healthy subjects
Description:
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
Description:
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.

Trial contacts and locations

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Central trial contact

Giuditta Benincasa, PhD

Data sourced from clinicaltrials.gov

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