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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03076580
Other study ID # BeijingIHLBVD2016031
Secondary ID
Status Recruiting
Phase
First received March 1, 2017
Last updated April 17, 2018
Start date July 1, 2015
Est. completion date December 31, 2021

Study information

Verified date March 2017
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact Jie Du, PhD
Email jiedubj@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2021
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China Beijing Institute of heart, lung and blood vessel diseases Beijing Beijing
China Beijing Institute of heart, lung and blood vessel diseases Beijing Beijing
China Shijie You Beijing

Sponsors (3)

Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases Beijing Anzhen Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Age for each participant These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary gender for each participant These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary Height for each participant These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary Weight for each participant These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary 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
Secondary 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
Secondary blood lipids(LDL,HDL,VLDL) These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary creatine These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary urea These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary blood glucose These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary D-dimer These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary hsCRP These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Secondary All-cause death The data is collected during follow-up visit at 1/3/5 years after discharge One year/Three year/Five year
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary RNA/micro RNA/long-noncoding RNA-sequencing data The data is collected from lab in an average of 6 month after the sample recruiting
Secondary 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
Secondary Exon sequencing data The data is collected from lab in an average of 6 month after the sample recruiting
Secondary 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
Secondary 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
Secondary Result of echocardiography-E/A Ratio The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function. Three year
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