Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Chinese Hypertrophic Cardiomyopathy Study(CHCS) (CHCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696135
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lei.Song@NCCD, 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.

Condition or disease
Cardiomyopathy, Hypertrophic

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
Actual Study Start Date : March 23, 2011
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2028


Group/Cohort
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.



Primary Outcome Measures :
  1. Cardiovascular deaths [ Time Frame: an average of 2 years ]
    Including SCD and deaths due to heart failure and stroke.


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Biospecimens retained include blood, serum, plasma, and myocardium when the patients receive cardio myectomy surgery.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCM are recruited from multiple centers in China between March 23, 2016 and December 31, 2025.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696135


Contacts
Layout table for location contacts
Contact: Song Lei, MD.&ph.D 86-13810532620 clinicalfw@163.com
Contact: Song Lei, MD.&ph.D 86-18600197655 clinicalfw@163.com

Locations
Layout table for location information
China, Beijing
Fuwai hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Lei Song, MD.& PhD.    86-13810532620    clinicalfw@163.com   
Contact: Lei Song, MD.& PhD.    86-18600197655    lsongqd@yahoo.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Layout table for investigator information
Principal Investigator: Song Lei, MD.&ph.D Fuwai Hospital

Layout table for additonal information
Responsible Party: Lei.Song@NCCD, MD.&ph.D, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT02696135     History of Changes
Other Study ID Numbers: CHCS
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lei.Song@NCCD, China National Center for Cardiovascular Diseases:
hypertrophic cardiomyopathy
clinical outcomes
multi-omics
risk stratification
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases