The Chinese Hypertrophic Cardiomyopathy Study(CHCS)

Recruiting

• Conditions: Cardiomyopathy, Hypertrophic

• Registration Number: NCT02696135
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-03-23
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-24
• Last Update Posted: 2018-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular deaths	an average of 2 years	Including SCD and deaths due to heart failure and stroke.

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	an average of 2 years.	deaths due to all causes.
Heart failure	an average of 2 years	Progress to level III or IV in New York Heart Association class.
Stroke	an average of 2 years	including cerebral infarction and hemorrhage
Malignant arrhythmia	an average of 2 years	The incidence rate of malignant arrhythmia

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China