Clinical trial NCT03880708: China Inherited Ventricular Arrhythmias Registry
Official title: China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Arrythmia
Keywords: brugada syndrome
long QT syndrome
short QT syndrome
early repolarization syndrome
catecholaminergic polymorphic ventricular tachycardia
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Renmin Hospital of Wuhan University
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital of Nanchang University
name: Sir Run Run Shaw Hospital
name: West China Hospital
name: Beijing Anzhen Hospital
name: General Hospital of Shenyang Military Region
name: Xuzhou Central Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2019-03-19
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: sustained tachycardia/ ventricular fibrillation or sudden cardiac death
timeFrame: 5 years
Secondary outcomes:
measure: episodes of arrhythmia
timeFrame: 5 years
measure: all-cause death
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Yan YAO, MD, PhD
role: STUDY_CHAIR
References: