Brugada SyndromeANDROMEDANCT06888271
DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death
An observational study of Brugada Syndrome and Sudden Cardiac Death Due to Cardiac Arrhythmia, run by University of Campania Luigi Vanvitelli.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brugada Syndrome, Sudden Cardiac Death Due to Cardiac Arrhythmia
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Related patients
- Not type 1 Br patter
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)
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?
Read the 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.
- Keywords
- DNA methylation, Liquid biopsy, Sudden cardiac death, Brugada syndrome
- Medical subject headings
- Brugada Syndrome, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuditta Benincasa, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888271
- Sponsor's protocol ID
- Vanvitelli-Benincasa G
- Other IDs
- PE00000015
- Acronym
- ANDROMEDA
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39725721
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)
- ClinicalTrials.gov ID
- NCT06888271
- Acronym / sponsor ID
- ANDROMEDA / Vanvitelli-Benincasa G
- Keywords
- DNA methylation, Liquid biopsy, Sudden cardiac death, Brugada syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Related patients
- Not type 1 Br patter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of differentially methylated genes as assessed by EPIC microarray
Time frame: 3 months
We will compare the methylation profiles of patients and controls in order to obtain a panel of differentially methylated genes.
1 secondary outcome
Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 39725721Benincasa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome and Sudden Cardiac Death Due to Cardiac Arrhythmia, run by University of Campania Luigi Vanvitelli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuditta Benincasa, PhD (0815667916, giuditta.benincasa@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differentially methylated genes as assessed by EPIC microarray (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.