Clinical trial NCT03076580: An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China
Official title: An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Left Ventricular Non-compaction
Restrictive Cardiomyopathy
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Beijing Anzhen Hospital
First posted: 2017-03-10
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
timeFrame: Five year
Secondary outcomes:
measure: Age for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: gender for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Height for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Weight for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Past medical history for each participant including disease history, surgical history, and family
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Life style for each participant including smoking history and drinking, specify how many years
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood lipids(LDL,HDL,VLDL)
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: creatine
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: urea
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood glucose
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: D-dimer
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: hsCRP
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: All-cause death
timeFrame: One year/Three year/Five year
measure: Re-hospitalization
timeFrame: One year/Three year/Five year
measure: Heart transplantation
timeFrame: One year/Three year/Five year
measure: Malignant arrythmia
timeFrame: One year/Three year/Five year
measure: Worsening heart failure
timeFrame: One year/Three year/Five year
measure: RNA/micro RNA/long-noncoding RNA-sequencing data
timeFrame: The data is collected from lab in an average of 6 month after the sample recruiting
measure: Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample
timeFrame: The data is collected from lab in an average of 6 month after the sample recruiting
measure: Exon sequencing data
timeFrame: The data is collected from lab in an average of 6 month after the sample recruiting
measure: Result of echocardiography-Ejection Fraction
timeFrame: Three year
measure: Result of echocardiography-Left Ventricular End Diastolic Diameter
timeFrame: Three year
measure: Result of echocardiography-E/A Ratio
timeFrame: Three year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of heart, lung and blood vessel diseases
state: Beijing
city: Beijing
country: China
facility: Beijing Institute of heart, lung and blood vessel diseases
state: Beijing
city: Beijing
country: China
facility: Shijie You
Study officials:
affiliation: Beijing Anzhen Hospital affiliated to Capital Medical University
name: Jie Du, PhD
role: STUDY_CHAIR
References: