Metabolomic Study of All-age Cardiomyopathy

N/AUnknownNCT03061994

Beijing Institute of Heart, Lung and Blood Vessel Diseases1,000 enrolled

Overview

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.

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

Enrollment

1,000

Conditions

Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Non-compaction

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Result of echocardiography

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.

Time frame: three year

Secondary Outcomes

Cardiovascular death

The data is collected during follow-up visit at 1/3 years after discharge

Time frame: One year/Three year

Re-hospitalization

patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction (LVEF) or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge

Time frame: One year/Three year

Heart transplantation

patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge

Time frame: One year/Three year

malignant arrythmia

Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.

Time frame: One year/Three year

Worsening heart failure

Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction \<45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36 months after enrollment.

Time frame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting

Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample

The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.

Time frame: The data is collected from lab in an average of 3 month after the sample recruiting

Metabolomic Study of All-age Cardiomyopathy

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts