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

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Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT03076580
BeijingIHLBVD2016031

Details and patient eligibility

About

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.

Full 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

Enrollment

2,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

2,000 participants in 3 patient groups

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

Trial contacts and locations

2

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Central trial contact

Jie Du, PhD; Yulin Li, PhD

Data sourced from clinicaltrials.gov

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