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

Hypertrophic Cardiomyopathy Clinical Trial

— AOCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076580
• Other study ID #: BeijingIHLBVD2016031
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Left Ventricular Non-compaction
• Restrictive Cardiomyopathy

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