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RecruitingNCT03880708Updated Mar 26, 2019

China Inherited Ventricular Arrhythmias Registry

An observational study in Ventricular Arrythmia, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 1 Hour to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2022, 3 years 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2017; still recruiting 8 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
1 Hour to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ventricular Arrythmia

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Keywords

  • brugada syndrome
  • long QT syndrome
  • short QT syndrome
  • early repolarization syndrome
  • catecholaminergic polymorphic ventricular tachycardia
03

In context

Arrhythmias, Cardiac

886 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 415 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In 10 major arrhythmia centers distributed in 6 areas in China, 500 patients satisfying the inclusion criteria will be enrolled consecutively

Inclusion criteria

  • diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).

Exclusion criteria

Exclusion Criteria:

  • patients were enrolled by other clinical trials.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. sustained tachycardia/ ventricular fibrillation or sudden cardiac death

    event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death

    Time frame: 5 years

Secondary outcomes

  1. episodes of arrhythmia

    type of arrhythmia, the amount of episodes, duration, unstable hemodynamics, treatment

    Time frame: 5 years

  2. all-cause death

    exclude accidents, like trauma, drowning

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • China National Center for Cardiovascular Diseases
    Beijing, Beijing 100037, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03880708
Lead sponsor
China National Center for Cardiovascular Diseases
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
First posted
Mar 19, 2019
Start date
Oct 24, 2017
Primary completion
Oct 24, 2022 (estimated)
Completion
Oct 24, 2027 (estimated)
Last update
Mar 26, 2019

Study contacts

Yan YAO, MD,PhD
Contact
ianyao@263.net.cn
+86-13901121319
Shangyu LIU, MD
Contact
liushangyu_yu_fw@163.com
+86-18800161355
Yan YAO, MD, PhD
study chair · China National Center for Cardiovascular Diseases

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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