Southeast Asian Brugada Syndrome Cohort

Brugada Syndrome Clinical Trial

— SEA-BrS  

Official title:

Discovering the Genetic Causes of Brugada Syndrome in Thais and Southeast Asian Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232787
• Other study ID #: 2558-114
• Status: Recruiting
• Start date: January 28, 2016
• Est. completion date: January 2023

Study information

• Verified date: January 2020
• Source: Chulalongkorn University
• Contact: Apichai Khongphatthanayothin, MD
• Phone: 66891555545
• Email: apichaik[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Brugada syndrome (BrS) is the leading cause of sudden death in young Asian adults including Thailand. This syndrome may be hereditary and involve mutations in certain genes. Aim of the study is to identify the relationship between genetic variants and the diagnosis/clinical severity of patients with BrS.

Description:

This cohort study recruits BrS patients with confirmed Brugada type 1 ECG and healthy volunteers in Thailand. Data collection consists of demographic, clinical data, ECG and blood sample for genetic studies. Genotyping was done by whole genome sequencing and SNP array then compared between cases and controls. Each BrS patient will be followed up prospectively for symptoms and AICD shock. Subsequently, the study will analyze relationship between genetic variants and clinical data against clinical severity of BrS patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 2023
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Thai nationality

• The patient has at least one of confirmed Brugada type 1 ECG in at least one of right precordial leads (v1 or v2) with or without pharmacologic provocative testing. The confirmed ECG is standard 12 lead ECG or Brugada lead

Exclusion Criteria:

• The patient has other cardiac diseases such as ischemic heart disease, valvular heart disease, congenital heart disease, myocarditis and pericarditis

• The patient has type 2 or type 3 Brugada ECG without type 1 ECG during pharmacologic provocative testing and/or Brugada lead

• The patient had one time of Brugada type 1 ECG during drug use without reproducibility

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Locations

Country	Name	City	State
Thailand	Bangkok Hospital	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok
Thailand	Faculty of Medicine, Chiang Mai University	Chiang Mai
Thailand	Vajira Hospital	Dusit	Bangkok
Thailand	Queen Sirikit Heart Center of the Northeast	Khon Kaen
Thailand	Central Chest Hospital	Nonthaburi
Thailand	Chulalongkorn University	Pathum Wan	Bangkok
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok
Thailand	Bhumibol Adulyadej RTAF Hospital	Sai Mai	Bangkok
Thailand	Bumrungrad International Hospital	Watthana	Bangkok
Thailand	Pacific Rim Electrophysiology Research Institute Data Coordinating Center	Watthana	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Bezzina CR, Barc J, Mizusawa Y, Remme CA, Gourraud JB, Simonet F, Verkerk AO, Schwartz PJ, Crotti L, Dagradi F, Guicheney P, Fressart V, Leenhardt A, Antzelevitch C, Bartkowiak S, Borggrefe M, Schimpf R, Schulze-Bahr E, Zumhagen S, Behr ER, Bastiaenen R, — View Citation

Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012 Jan 31;125(4):620-37. doi: 10.1161/CIRCULATIONAHA.111.023838. — View Citation

Nademanee K, Veerakul G, Nimmannit S, Chaowakul V, Bhuripanyo K, Likittanasombat K, Tunsanga K, Kuasirikul S, Malasit P, Tansupasawadikul S, Tatsanavivat P. Arrhythmogenic marker for the sudden unexplained death syndrome in Thai men. Circulation. 1997 Oct — View Citation

Priori SG, Wilde AA, Horie M, Cho Y, Behr ER, Berul C, Blom N, Brugada J, Chiang CE, Huikuri H, Kannankeril P, Krahn A, Leenhardt A, Moss A, Schwartz PJ, Shimizu W, Tomaselli G, Tracy C. HRS/EHRA/APHRS expert consensus statement on the diagnosis and manag — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype)	Case-Control study of genetic variants in BrS cases vs controls. Genetic study was done by whole genome sequencing and SNP array. Association analysis assessed by polygenic risk score and regression coefficients.	7 years
Secondary	Natural history of Brugada syndrome (survival from arrhythmic events)	Cohort study to followed up BrS patients with or with arrhythmic events which assessed by survival curve analysis.	7 years
Secondary	Epidemiology of Brugada syndrome	To study prevalence of Brugada syndrome in Thailand.	7 years

External Links

•   Project database