China Inherited Ventricular Arrhythmias Registry

Recruiting

• Conditions: Ventricular Arrythmia

• Registration Number: NCT03880708
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

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 Timeline

• Study Start: 2017-10-24
• Status Verified: 2018-10
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26
• Primary Completion: 2022-10-24
• Study Completion: 2027-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sustained tachycardia/ ventricular fibrillation or sudden cardiac death	5 years	event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death

Secondary Outcome Measures

Name	Time	Method
all-cause death	5 years	exclude accidents, like trauma, drowning
episodes of arrhythmia	5 years	type of arrhythmia, the amount of episodes, duration, unstable hemodynamics, treatment

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China