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NCT Number: NCT03880708

China Inherited Ventricular Arrhythmias Registry

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • patients were enrolled by other clinical trials.

Treatment and study plan

Primary outcomes

  1. sustained tachycardia/ ventricular fibrillation or sudden cardiac death

    Time frame: 5 years

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

Secondary outcomes

  1. episodes of arrhythmia

    Time frame: 5 years

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

  2. all-cause death

    Time frame: 5 years

    exclude accidents, like trauma, drowning

Study contacts

Contact information is provided by the study sponsor or research team.

Shangyu LIU, MD

CONTACT

[email protected]

+86-18800161355

Yan YAO, MD,PhD

CONTACT

[email protected]

+86-13901121319

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Beijing Anzhen Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • General Hospital of Shenyang Military Region
  • Renmin Hospital of Wuhan University
  • Second Affiliated Hospital of Nanchang University
  • Sir Run Run Shaw Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • West China Hospital
  • Xuzhou Central Hospital

Registry information

Official study title

China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2027
First posted
Mar 19, 2019
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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