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

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ClinicalTrials.gov Identifier: NCT03076580
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing Anzhen Hospital
Information provided by (Responsible Party):
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.

Condition or disease
Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Non-compaction Restrictive Cardiomyopathy

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

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 31, 2021


Group/Cohort
cardiomyopathy
Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
disease control
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
Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.



Primary Outcome Measures :
  1. The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy. [ Time Frame: 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 :
  1. Age for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  2. gender for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  3. Height for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  4. Weight for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  5. Past medical history for each participant including disease history, surgical history, and family [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  6. Life style for each participant including smoking history and drinking, specify how many years [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  7. blood lipids(LDL,HDL,VLDL) [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  8. creatine [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  9. urea [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  10. blood glucose [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  11. D-dimer [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  12. hsCRP [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  13. All-cause death [ Time Frame: One year/Three year/Five year ]
    The data is collected during follow-up visit at 1/3/5 years after discharge

  14. Re-hospitalization [ Time Frame: 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

  15. Heart transplantation [ Time Frame: 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

  16. Malignant arrythmia [ Time Frame: 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.

  17. Worsening heart failure [ Time Frame: 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.

  18. RNA/micro RNA/long-noncoding RNA-sequencing data [ Time Frame: The data is collected from lab in an average of 6 month after the sample recruiting ]
  19. Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample [ Time Frame: The data is collected from lab in an average of 6 month after the sample recruiting ]
  20. Exon sequencing data [ Time Frame: The data is collected from lab in an average of 6 month after the sample recruiting ]
  21. Result of echocardiography-Ejection Fraction [ Time Frame: 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.

  22. Result of echocardiography-Left Ventricular End Diastolic Diameter [ Time Frame: 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.

  23. Result of echocardiography-E/A Ratio [ Time Frame: Three year ]
    The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.


Biospecimen Retention:   Samples With DNA
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence.

Patients have smiliar symptoms and are suspected as cardiomyopathy and further excluded by imaging examnation.

age- and gender- mathced healthy controls are also recuitted in the hospital.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076580


Contacts
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Contact: Jie Du, PhD jiedubj@126.com
Contact: Yulin Li, PhD lyllyl_1111@163.com

Locations
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China, Beijing
Beijing Institute of heart, lung and blood vessel diseases Recruiting
Beijing, Beijing, China
Contact: Jie Du       jiedubj@126.com   
Contact: Yulin Li       lyllyl_1111@163.com   
Sub-Investigator: Yang Li, PhD         
Sub-Investigator: Hongzhao You, MS         
Beijing Institute of heart, lung and blood vessel diseases Recruiting
Beijing, Beijing, China
Contact: Jie Du       jiedubj@126.com   
Contact: Yulin Li       lyllyl_1111@163.com   
Sub-Investigator: Yang Li, PhD         
Sub-Investigator: Hongzhao You, MS         
Principal Investigator: Yongqiang Lai, MD         
China
Shijie You Enrolling by invitation
Beijing, China
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing Anzhen Hospital
Investigators
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Study Chair: Jie Du, PhD Beijing Anzhen Hospital affiliated to Capital Medical University

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Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT03076580     History of Changes
Other Study ID Numbers: BeijingIHLBVD2016031
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Cardiomyopathy, Restrictive
Arrhythmogenic Right Ventricular Dysplasia
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities