The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
CHCS
1 other identifier
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2011
CompletedFirst Submitted
Initial submission to the registry
January 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedMarch 27, 2018
March 1, 2018
14.8 years
January 26, 2016
March 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular deaths
Including SCD and deaths due to heart failure and stroke.
an average of 2 years
Secondary Outcomes (4)
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
Study Arms (1)
Hypertrophic cardiomyopathy
Individuals with an 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, in the absence of other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy.
Eligibility Criteria
Patients with HCM are recruited from multiple centers in China between March 23, 2016 and December 31, 2025.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai hospital
Beijing, Beijing Municipality, 100037, China
Biospecimen
Biospecimens retained include blood, serum, plasma, and myocardium when the patients receive cardio myectomy surgery.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Song Lei, MD.&ph.D
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD.&ph.D
Study Record Dates
First Submitted
January 26, 2016
First Posted
March 2, 2016
Study Start
March 23, 2011
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2028
Last Updated
March 27, 2018
Record last verified: 2018-03