The Chinese Hypertrophic Cardiomyopathy Study(CHCS)

Cardiomyopathy, Hypertrophic Clinical Trial

— CHCS  

Official title:

The Chinese Hypertrophic Cardiomyopathy Study(CHCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02696135
• Other study ID #: CHCS
• Status: Recruiting
• First received: January 26, 2016
• Last updated: March 24, 2018
• Start date: March 23, 2011
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2018
• Source: China National Center for Cardiovascular Diseases
• Contact: Song Lei, MD.&ph.D
• Phone: 86-13810532620
• Email: clinicalfw[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria: Patients with HCM diagnosed by observation of unexplained maximal left ventricle wall thickness =15 mm on echocardiography and/or cardiac magnetic resonance imaging or or =13 mm for individuals with family history of HCM.

Exclusion criteria: Individuals with other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular deaths	Including SCD and deaths due to heart failure and stroke.	an average of 2 years
Secondary	all-cause mortality	deaths due to all causes.	an average of 2 years.
Secondary	Heart failure	Progress to level III or IV in New York Heart Association class.	an average of 2 years
Secondary	Stroke	including cerebral infarction and hemorrhage	an average of 2 years
Secondary	Malignant arrhythmia	The incidence rate of malignant arrhythmia	an average of 2 years