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

An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Enrolling by invitation
    • Shijie You
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Institute of Heart, Lung and Blood Vessel Diseases
      • Contact: Jie Du; Email: jiedubj@126.com
      • Contact: Yulin Li; Email: lyllyl_1111@163.com
      • Sub-Investigator: Yang Li, PhD
      • Sub-Investigator: Hongzhao You, MS
      • Principal Investigator: Yongqiang Lai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
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
gender 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
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 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
blood glucose		These data is collected from the cases' medical record in an average of 1 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
hsCRP		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
All-cause death	The data is collected during follow-up visit at 1/3/5 years after discharge	One year/Three year/Five year
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
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
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
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
RNA/micro RNA/long-noncoding RNA-sequencing data		The data is collected from lab in an average of 6 month after the sample recruiting
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
Exon sequencing data		The data is collected from lab in an average of 6 month after the sample recruiting
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
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
Result of echocardiography-E/A Ratio	The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.	Three year

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Collaborators: Beijing Anzhen Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Study Chair: Jie Du, PhD, Beijing Anzhen Hospital Affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Aortic Valve Disease; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiomegaly; Laminopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Restrictive
• Other Study ID Numbers: BeijingIHLBVD2016031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No