The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Cardiovascular deaths
研究概览
简要总结
Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM. Although about half of the patients were found to be caused by mutations mainly located in genes encoding sarcomere proteins, the causes in a significant proportion of patients with HCM are still unknown. Even in the patients with sarcomere mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to be revealed. Furthermore, HCM presents with significant heterogeneity. SCD risk stratification and prevention by ICD are necessary. However, the strategy of SCD risk stratification recommended by the 2011 ACCF/AHA and 2014 ESC guidelines were based mainly on the evidence derived from American and European countries. The accuracy of these guidelines in Chines patients with HCM was not evaluated yet.
详细描述
In the present study, patients with HCM are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hr Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood for all patients and myocardium for patients receive surgery of myocardial myectomy. Multi-omics screening, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, will be performed to identified novel disease genes, signal pathway or processes, genetic risk factors and potential therapy targets of HCM. Furthermore, besides examining the accuracy of SCD risk prediction of the 2011 ACCF/AHA and 2014 ESC guidelines, we will identify novel risk factors associated with the clinical outcomes and construct predictive models suitable for Chinese patients with HCM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cardiovascular deaths
时间窗: an average of 2 years
Including SCD and deaths due to heart failure and stroke.
次要结局
- all-cause mortality(an average of 2 years.)
- Heart failure(an average of 2 years)
- Stroke(an average of 2 years)
- Malignant arrhythmia(an average of 2 years)
研究者
Lei.Song@NCCD
MD.&ph.D
China National Center for Cardiovascular Diseases