Ventricular ArrythmiaNCT03880708
China Inherited Ventricular Arrhythmias Registry
An observational study of Ventricular Arrythmia, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular… Read more about this study
- Who is it for?
- Ages 1 hour to 90 years
- Conditions the study is for
- Ventricular Arrythmia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2017to 24 Oct 2027
- 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 1 hour to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In 10 major arrhythmia centers distributed in 6 areas in China, 500 patients satisfying the inclusion criteria will be enrolled consecutively
Who may be able to join
- diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).
Who cannot join
- patients were enrolled by other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Yan YAO, MD, PhD, +86-13901121319, ianyao@263.net.cn
Shangyu LIU, MD, +86-18800161355, liushangyu_fw@163.com
About this study
Official title: China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study
This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular tachycardia(CPVT). 500 participants will be recruited from 10 centers in China, with clinical data to be abstracted from medical records, and blood samples to be collected for finding related genes and promising risk indicators. The follow-up should be made every 6 months.
Read the detailed description
In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition, mainstream treatment relies on implantable devices and medication. China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as an efficient and economic strategy for early prevention and treatment.
Inherited Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well-trained staffs. At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.
- Conditions
- Ventricular Arrythmia
- Keywords
- brugada syndrome, long QT syndrome, short QT syndrome, early repolarization syndrome, catecholaminergic polymorphic ventricular tachycardia
- Medical subject headings
- Brugada Syndrome, Long QT Syndrome, Short Qt Syndrome, Polymorphic Catecholaminergic Ventricular Tachycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained tachycardia/ ventricular fibrillation or sudden cardiac death
event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
Measured: 5 years
Secondary outcomes (2)
episodes of arrhythmia
type of arrhythmia, the amount of episodes, duration, unstable hemodynamics, treatment
Measured: 5 years
all-cause death
exclude accidents, like trauma, drowning
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start24 Oct 2017
- Primary completion24 Oct 2022 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Renmin Hospital of Wuhan University, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Nanchang University, Sir Run Run Shaw Hospital, West China Hospital, Beijing Anzhen Hospital, General Hospital of Shenyang Military Region, Xuzhou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Yan YAO, MD, PhD, Study chair, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880708
- Sponsor's protocol ID
- 2017-950-2
- Status last verified
- Oct 2018
- First submitted
- 17 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study
- ClinicalTrials.gov ID
- NCT03880708
- Acronym / sponsor ID
- 2017-950-2
- Conditions
- Ventricular Arrythmia
- Keywords
- brugada syndrome, long QT syndrome, short QT syndrome, early repolarization syndrome, catecholaminergic polymorphic ventricular tachycardia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Renmin Hospital of Wuhan University, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Nanchang University, Sir Run Run Shaw Hospital, West China Hospital, Beijing Anzhen Hospital, General Hospital of Shenyang Military Region, Xuzhou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 24 Oct 2022 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 19 Mar 2019 (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.
This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular tachycardia(CPVT). 500 participants will be recruited from 10 centers in China, with clinical data to be abstracted from medical records, and blood samples to be collected for finding related genes and promising risk indicators. The follow-up should be made every 6 months.
Detailed description
In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition, mainstream treatment relies on implantable devices and medication. China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as an efficient and economic strategy for early prevention and treatment.
Inherited Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well-trained staffs. At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In 10 major arrhythmia centers distributed in 6 areas in China, 500 patients satisfying the inclusion criteria will be enrolled consecutively
Key inclusion criteria (1 listed)
- diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).
Key exclusion criteria (1 listed)
- patients were enrolled by other clinical trials.
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
sustained tachycardia/ ventricular fibrillation or sudden cardiac death
Time frame: 5 years
event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
2 secondary outcomes
episodes of arrhythmia
Time frame: 5 years
all-cause death
Time frame: 5 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 26 Mar 2019.
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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.
Yan YAO, MD, PhD study chair
China National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmia, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 1 inclusion and 1 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Yan YAO, MD,PhD (+86-13901121319, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained tachycardia/ ventricular fibrillation or sudden cardiac death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2019.