Metabolomic Study of Patients With Cardiomyopathy in China
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Result of echocardiography
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- •Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures
Exclusion Criteria
- •Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
- •History of rheumatic fever
- •Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
- •HIV infection or born to an HIV positive mother
- •Kawasaki disease
- •Immunologic disease
- •Uremia, active or chronic
- •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
Outcomes
Primary Outcomes
Result of echocardiography
Time Frame: three year
The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.
Secondary Outcomes
- Cardiovascular death(One year/Three year)
- Heart transplantation(One year/Three year)
- Re-hospitalization(One year/Three year)
- malignant arrythmia(One year/Three year)
- Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample(The data is collected from lab in an average of 3 month after the sample recruiting)
- Worsening heart failure(These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting)