Brief Title
An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China
Official Title
An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
Brief Summary
This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine
genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.
Detailed Description
Identification of novel biomarkers is needed to improve the diagnosis and prognosis of
cardiomyopathy. Also,the marked variation of genes which is still unclear, may influence
clinical outcomes is determined in part by genetic heterogeneity of the systemic response to
pathological process.
Specific aim:
1. Proteomics, microRNA-seq and metabolomics will be to determine the correlation of
echocardiographic parameters of systolic and diastolic functional entry with circulating
molecules
2. Genomics will be to determine the association of clinical outcome
Study Type
Observational
Primary Outcome
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
Secondary Outcome
Age for each participant
Condition
Dilated Cardiomyopathy
Study Arms / Comparison Groups
cardiomyopathy
Description: Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2000
Start Date
July 1, 2015
Completion Date
December 31, 2021
Primary Completion Date
July 1, 2018
Eligibility Criteria
Inclusion Criteria:
1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms,
laboratory tests including ECG, echocardiography.
2. Subject understands study requirements aand agrees to sign an informed consent form
prior to any study procedures.
Exclusion Criteria:
1. Endocrine disease known to cause heart muscle disease (including infants of diabetic
mothers)
2. History of rheumatic fever
3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal
radiation, iron overload or heavy metal exposure)
4. HIV infection or born to an HIV positive mother
5. Kawasaki disease
6. Immunologic disease
7. Uremia, active or chronic
8. Abnormal ventricular size or function that can be attributed to intense 9.physical
training or chronic anemia
10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the
onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose
cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary
parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary
hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth
hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jie Du, PhD, , [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03076580
Organization ID
BeijingIHLBVD2016031
Responsible Party
Sponsor
Study Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor
Jie Du, PhD, Study Chair, Beijing Anzhen Hospital affiliated to Capital Medical University
Verification Date
March 2017