Brugada SyndromeSEA-BrSNCT04232787
Southeast Asian Brugada Syndrome Cohort
An observational study of Brugada Syndrome, run by Chulalongkorn University at 11 sites in Thailand.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brugada Syndrome
- How many people
- 750 participants
- Where
- 11 sitesThailand
- Study dates
- 28 Jan 2016to 5 Jan 2031
- How long will I take part?
- 7 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Thai Brugada syndrome patients and healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Thailand11 sites, 11 recruiting
- Recruiting
Bangkok Hospital
Bangkok, Bangkok, 10310
Apichai Khongphatthanayothin, MD, 66891555545, apichaik@yahoo.com
Apichai Khongphatthanayothin, MD
- Recruiting
Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Rungroj Krittayaphong, MD, 66818059992, rungroj.kri@mahidol.ac.th
Rungroj Krittayaphong, MD
- Recruiting
Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
Wanwarang Wongcharoen, MD, 66897001604, bwanwarang@yahoo.com
Wanwarang Wongcharoen, MD
- Recruiting
Vajira Hospital
Dusit, Bangkok, 10300
Thaveekiat Vasavakul, MD, 66814515421, thaveekiat@hotmail.com
Thaveekiat Vasavakul, MD
- Recruiting
Queen Sirikit Heart Center of the Northeast
Khon Kaen, Changwat Khon Kaen, 40002
Pattarapong Makarawate, MD, 66816614751, pattarapong@kku.ac.th
Pattarapong Makarawate, MD
- Recruiting
Central Chest Hospital
Nonthaburi, Changwat Nonthaburi, 11000
Alisara Anannab, MD, 66819380010, alicera_24@hotmail.com
Alisara Anannab, MD
- Recruiting
Chulalongkorn University
Pathum Wan, Bangkok, 10330
Apichai Khongphatthanayothin, MD, 66891555545, apichaik@yahoo.com
Pharawee Wandee, BSc, 66944174331, brugadaproject@gmail.com
- Recruiting
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
Tachapong Ngamukos, MD, 66819241527, tetng@mahidol.ac.th
Tachapong Ngamukos, MD
- Recruiting
Bhumibol Adulyadej RTAF Hospital
Sai Mai, Bangkok, 10220
Gumpanart Veetakul, MD, gumprevention@gmail.com
Gumpanart Veetakul, MD
- Recruiting
Bumrungrad International Hospital
Vadhana, Bangkok, 10110
Koonlawee Nademanee, MD, 66870708787, koonlawee@pacificrimep.com
Koonlawee Nademanee
- Recruiting
Pacific Rim Electrophysiology Research Institute Data Coordinating Center
Vadhana, Bangkok, 10110
Koonlawee Nademanee, MD, 66870708787, koonlawee@pacificrimep.com
Koonlawee Nademanee, MD
About this study
Official title: Discovering the Genetic Causes of Brugada Syndrome in Thais and Southeast Asian Population
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.
Read the detailed 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.
- Conditions
- Brugada Syndrome
- Keywords
- Brugada Syndrome, Genetics, Epidemiology, Thai, Southeast Asia
- Medical subject headings
- Brugada Syndrome
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 |
|---|---|---|
| Case | Thai patients with diagnosed Brugada syndrome by confirmed Brugada type 1 ECG. | |
| Control | Healthy volunteers without Brugada marker from ECG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 years
Secondary outcomes (2)
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.
Measured: 7 years
Epidemiology of Brugada syndrome
To study prevalence of Brugada syndrome in Thailand.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start28 Jan 2016
- Primary completion5 Jan 2031 (estimated)
- Study completion5 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Apichai Khongphatthanayothin, MD, Chulalongkorn University
- Investigators
- Koonlawee Nademanee, MD, Study chair, Chulalongkorn UniversityYong Poovorawan, MD, Study director, Chulalongkorn UniversityApichai Khongphatthanayothin, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232787
- Sponsor's protocol ID
- 2558-114
- Acronym
- SEA-BrS
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Medical journals, abstract submissions and results database
Publications
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. No abstract available.
PubMed 22294707Priori 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 management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. 2013 Dec;10(12):1932-63. doi: 10.1016/j.hrthm.2013.05.014. Epub 2013 Aug 30. No abstract available.
PubMed 24011539Nademanee 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 21;96(8):2595-600. doi: 10.1161/01.cir.96.8.2595.
PubMed 9355899Bezzina 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, Tfelt-Hansen J, Olesen MS, Kaab S, Beckmann BM, Weeke P, Watanabe H, Endo N, Minamino T, Horie M, Ohno S, Hasegawa K, Makita N, Nogami A, Shimizu W, Aiba T, Froguel P, Balkau B, Lantieri O, Torchio M, Wiese C, Weber D, Wolswinkel R, Coronel R, Boukens BJ, Bezieau S, Charpentier E, Chatel S, Despres A, Gros F, Kyndt F, Lecointe S, Lindenbaum P, Portero V, Violleau J, Gessler M, Tan HL, Roden DM, Christoffels VM, Le Marec H, Wilde AA, Probst V, Schott JJ, Dina C, Redon R. Common variants at SCN5A-SCN10A and HEY2 are associated with Brugada syndrome, a rare disease with high risk of sudden cardiac death. Nat Genet. 2013 Sep;45(9):1044-9. doi: 10.1038/ng.2712. Epub 2013 Jul 21.
PubMed 23872634Chimparlee N, Prechawat S, Khongphatthanayothin A, Mauleekoonphairoj J, Lekchuensakul S, Wongcharoen W, Makarawate P, Sahasatas D, Krittayaphong R, Amnueypol M, Anannab A, Ngarmukos T, Vardhanabhuti S, Sutjaporn B, Wandee P, Veerakul G, Bezzina CR, Poovorawan Y, Nademanee K. Clinical Characteristics of SCN5A p.R965C Carriers: A Common Founder Variant Predisposing to Brugada Syndrome in Thailand. Circ Genom Precis Med. 2021 Jun;14(3):e003229. doi: 10.1161/CIRCGEN.120.003229. Epub 2021 Jun 7. No abstract available.
PubMed 34092119Makarawate P, Glinge C, Khongphatthanayothin A, Walsh R, Mauleekoonphairoj J, Amnueypol M, Prechawat S, Wongcharoen W, Krittayaphong R, Anannab A, Lichtner P, Meitinger T, Tjong FVY, Lieve KVV, Amin AS, Sahasatas D, Ngarmukos T, Wichadakul D, Payungporn S, Sutjaporn B, Wandee P, Poovorawan Y, Tfelt-Hansen J, Tanck MWT, Tadros R, Wilde AAM, Bezzina CR, Veerakul G, Nademanee K. Common and rare susceptibility genetic variants predisposing to Brugada syndrome in Thailand. Heart Rhythm. 2020 Dec;17(12):2145-2153. doi: 10.1016/j.hrthm.2020.06.027. Epub 2020 Jun 30.
PubMed 32619740
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering the Genetic Causes of Brugada Syndrome in Thais and Southeast Asian Population
- ClinicalTrials.gov ID
- NCT04232787
- Acronym / sponsor ID
- SEA-BrS / 2558-114
- Conditions
- Brugada Syndrome
- Keywords
- Brugada Syndrome, Genetics, Epidemiology, Thai, Southeast Asia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 5 Jan 2031 (estimated)
- Study completion
- 5 Jan 2031 (estimated)
- First posted
- 18 Jan 2020 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Thai patients with diagnosed Brugada syndrome by confirmed Brugada type 1 ECG. |
| Control | – | –Healthy volunteers without Brugada marker from ECG. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thai Brugada syndrome patients and healthy volunteers
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype)
Time frame: 7 years
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.
2 secondary outcomes
Natural history of Brugada syndrome (survival from arrhythmic events)
Time frame: 7 years
Epidemiology of Brugada syndrome
Time frame: 7 years
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 30 Oct 2026.
- Results publication: PubMed 22294707Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012 Jan 31;125(4):620-37. doi: 10.1161/CIRCULATIONAHA.111.023838. No abstract available.
- Results publication: PubMed 24011539Priori 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 management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. 2013 Dec;10(12):1932-63. doi: 10.1016/j.hrthm.2013.05.014. Epub 2013 Aug 30. No abstract available.
- Results publication: PubMed 9355899Nademanee 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 21;96(8):2595-600. doi: 10.1161/01.cir.96.8.2595.
- Results publication: PubMed 23872634Bezzina 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, Tfelt-Hansen J, Olesen MS, Kaab S, Beckmann BM, Weeke P, Watanabe H, Endo N, Minamino T, Horie M, Ohno S, Hasegawa K, Makita N, Nogami A, Shimizu W, Aiba T, Froguel P, Balkau B, Lantieri O, Torchio M, Wiese C, Weber D, Wolswinkel R, Coronel R, Boukens BJ, Bezieau S, Charpentier E, Chatel S, Despres A, Gros F, Kyndt F, Lecointe S, Lindenbaum P, Portero V, Violleau J, Gessler M, Tan HL, Roden DM, Christoffels VM, Le Marec H, Wilde AA, Probst V, Schott JJ, Dina C, Redon R. Common variants at SCN5A-SCN10A and HEY2 are associated with Brugada syndrome, a rare disease with high risk of sudden cardiac death. Nat Genet. 2013 Sep;45(9):1044-9. doi: 10.1038/ng.2712. Epub 2013 Jul 21.
- Derived from this study: PubMed 34092119Chimparlee N, Prechawat S, Khongphatthanayothin A, Mauleekoonphairoj J, Lekchuensakul S, Wongcharoen W, Makarawate P, Sahasatas D, Krittayaphong R, Amnueypol M, Anannab A, Ngarmukos T, Vardhanabhuti S, Sutjaporn B, Wandee P, Veerakul G, Bezzina CR, Poovorawan Y, Nademanee K. Clinical Characteristics of SCN5A p.R965C Carriers: A Common Founder Variant Predisposing to Brugada Syndrome in Thailand. Circ Genom Precis Med. 2021 Jun;14(3):e003229. doi: 10.1161/CIRCGEN.120.003229. Epub 2021 Jun 7. No abstract available.
- Derived from this study: PubMed 32619740Makarawate P, Glinge C, Khongphatthanayothin A, Walsh R, Mauleekoonphairoj J, Amnueypol M, Prechawat S, Wongcharoen W, Krittayaphong R, Anannab A, Lichtner P, Meitinger T, Tjong FVY, Lieve KVV, Amin AS, Sahasatas D, Ngarmukos T, Wichadakul D, Payungporn S, Sutjaporn B, Wandee P, Poovorawan Y, Tfelt-Hansen J, Tanck MWT, Tadros R, Wilde AAM, Bezzina CR, Veerakul G, Nademanee K. Common and rare susceptibility genetic variants predisposing to Brugada syndrome in Thailand. Heart Rhythm. 2020 Dec;17(12):2145-2153. doi: 10.1016/j.hrthm.2020.06.027. Epub 2020 Jun 30.
- Project databaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Medical journals, abstract submissions and results database
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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.
Koonlawee Nademanee, MD study chair
Chulalongkorn University
Yong Poovorawan, MD study director
Chulalongkorn University
Apichai Khongphatthanayothin, MD principal investigator
Chulalongkorn University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by Chulalongkorn University at 11 sites in Thailand.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Apichai Khongphatthanayothin, MD (66891555545, apichaik@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype) (time frame: 7 years). 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 NCT04232787, which also lists 6 linked publications.
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 30 Oct 2026.