DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

ConditionsBrugada Syndrome Sudden Cardiac Death Due to Cardiac Arrhythmia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Campania Luigi Vanvitelli

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Related patients

Not type 1 Br patter

Trial 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).

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

10 Participants

are grouped into 2 trial groups

Group A: Healthy subjects

Group B: Brugada patients

Trial outcomes

Primary outcomes

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.

Time frame

3 months

Secondary outcomes

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

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.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Campania Luigi Vanvitelli

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: