Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02696135

The Chinese Hypertrophic Cardiomyopathy Study(CHCS)

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cardiovascular deaths

    Time frame: an average of 2 years

    Including SCD and deaths due to heart failure and stroke.

Secondary outcomes

  1. all-cause mortality

    Time frame: an average of 2 years.

    deaths due to all causes.

  2. Heart failure

    Time frame: an average of 2 years

    Progress to level III or IV in New York Heart Association class.

  3. Stroke

    Time frame: an average of 2 years

    including cerebral infarction and hemorrhage

  4. Malignant arrhythmia

    Time frame: an average of 2 years

    The incidence rate of malignant arrhythmia

Study contacts

Contact information is provided by the study sponsor or research team.

Song Lei, MD.&ph.D

CONTACT

[email protected]

86-13810532620

Song Lei, MD.&ph.D

CONTACT

[email protected]

86-18600197655

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: CHCS

Important dates

Study start
2011
Primary completion
2025
Study completion
2028
First posted
Mar 2, 2016
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.