Brief Title
Metabolomic Study of All-age Cardiomyopathy
Official Title
Metabolomic Study of Patients With Cardiomyopathy in China
Brief Summary
This study aims to 1)characterize the differentially expressed metabolites between
cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated
with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up
of a cohort and 3)to determine whether differentially expressed may affect the pathological
process of cardiomyopathies . Standardized protocols will be used for the assessment of
medical history and examinations, laboratory biomarkers, and the collection of blood plasma.
Detailed Description
The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in
order to identify biochemical markers with risk stratification and prognostic value. Clinical
data of enrolled patients regarding demographics, cardiovascular risk factors，clinical lab
data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6
months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call
when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled.
Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.
Study Type
Observational
Primary Outcome
Result of echocardiography
Secondary Outcome
Cardiovascular death
Condition
Dilated Cardiomyopathy
Study Arms / Comparison Groups
Cardiomyopathy
Description: Children(older than 18 years old) are diagnosed as cardiomyopathy by three cardiologists and recruited in pediatric heart center,Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. Adults are diagnosed as cardiomyopathy by three cardiologists and recruited in the department of cardiology ,Beijing Anzhen Hospital.
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
1000
Start Date
October 2016
Completion Date
October 2020
Primary Completion Date
October 2019
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
Yulin Li, PhD, , [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03061994
Organization ID
BeijingIHLBVD2016023
Responsible Party
Sponsor
Study Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Study Sponsor
Yulin Li, PhD, Study Director, Beijing anzhen hospital affiliated to capital medical university
Verification Date
March 2017