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

• Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy; Left Ventricular Non-compaction; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy; Restrictive Cardiomyopathy

• Registration Number: NCT03076580
• Lead Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

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 Timeline

• Study Start: 2015-07-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19
• Primary Completion: 2018-07-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.	Five year	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.

Secondary Outcome Measures

Name	Time	Method
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
hsCRP	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Re-hospitalization	One year/Three year/Five year	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
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
Age for each participant	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Malignant arrythmia	One year/Three year/Five year	Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
gender for each participant	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 glucose	These data is collected from the cases' medical record in an average of 1 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-Left Ventricular End Diastolic Diameter	Three year	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.
Result of echocardiography-E/A Ratio	Three year	The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.
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
RNA/micro RNA/long-noncoding RNA-sequencing data	The data is collected from lab in an average of 6 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
All-cause death	One year/Three year/Five year	The data is collected during follow-up visit at 1/3/5 years after discharge
Heart transplantation	One year/Three year/Five year	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
Worsening heart failure	One year/Three year/Five year	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.
Result of echocardiography-Ejection Fraction	Three year	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.

Trial Locations

Locations (2)

Beijing Institute of heart, lung and blood vessel diseases; 🇨🇳 Beijing, Beijing, China

Shijie You; 🇨🇳 Beijing, China