An Integrative-Omics Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China

Study Overview
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Brief Summary
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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
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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: Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules Genomics will be to determine the association of clinical outcome

Official Title
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An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China

Conditions
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Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction, Restrictive Cardiomyopathy

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiomyopathy<br>Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| disease control<br>Patients have similar symptoms with cardiomyopathy patients, and are further excluded by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| healthy control<br>Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy. | The primary objective of this study is to determine whether variation in genetic background or molecules influences clinical outcomes in cardiomyopathy. Differentially expressed molecules are reported in multi-omics. | Five year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age for each participant |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| gender for each participant |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Height for each participant |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Weight for each participant |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Past medical history for each participant including disease history, surgical history, and family |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Life style for each participant including smoking history and drinking, specify how many years |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| blood lipids(LDL,HDL,VLDL) |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| creatine |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| urea |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| blood glucose |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| D-dimer |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| hsCRP |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| All-cause death | The data is collected during follow-up visit at 1/3/5 years after discharge | One year/Three year/Five year | 
| Re-hospitalization | Patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction or worsen symptoms. The data is collected during follow-up visit at 1/3/5 years after discharge | One year/Three year/Five year | 
| Heart transplantation | Patients are underwent heart transplantation due to pump failure of heart.The data is collected during follow-up visit at 1/3 years after discharge | One year/Three year/Five 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. | One year/Three year/Five 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 3/6/9/12/36/60 months after enrollment. | One year/Three year/Five year | 
| RNA/micro RNA/long-noncoding RNA-sequencing data |  | The data is collected from lab in an average of 6 month after the sample recruiting | 
| Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample |  | The data is collected from lab in an average of 6 month after the sample recruiting | 
| Exon sequencing data |  | The data is collected from lab in an average of 6 month after the sample recruiting | 
| Result of echocardiography-Ejection Fraction | The whole results of echocardiography report will be recorded. The indicate can reflect cardiac contraction function and be used for discriminating heart failure or non-heart failure as a main factor. | Three year | 
| Result of echocardiography-Left Ventricular End Diastolic Diameter | The whole results of echocardiography report will be recorded. The indicate can reflect the size of heart and be used for determination of heart enlargement. | Three year | 
| Result of echocardiography-E/A Ratio | The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function. | Three year |