DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death

NCT ID: NCT06888271

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brugada Syndrome Sudden Cardiac Death Due to Cardiac Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giuditta Benincasa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Giuditta Benincasa, PhD

Role: CONTACT

0815667916

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 39725721 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PE00000015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Vanvitelli-Benincasa G

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mayo AVC Registry and Biobank
NCT03049254 RECRUITING
Molecular Autopsy Study
NCT02168088 RECRUITING
Genomics of Sudden Cardiac Arrest
NCT00661128 ACTIVE_NOT_RECRUITING
Cardiac AResT And GENEtic
NCT00604149 COMPLETED