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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03076580
Acronym
AOCC
Enrollment
2000
Registered
2017-03-10
Start date
2015-07-01
Completion date
2021-12-31
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

None listed

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
CollaboratorOTHER
Beijing Anzhen Hospital
CollaboratorOTHER
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.Five yearThe 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

MeasureTime frameDescription
Age for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
gender for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participantThese 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 familyThese 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 yearsThese 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
creatineThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
ureaThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood glucoseThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
D-dimerThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
hsCRPThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Re-hospitalizationOne year/Three year/Five yearPatients 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
Heart transplantationOne year/Three year/Five yearPatients are underwent heart transplantation due to pump failure of heart.The data is collected during follow-up visit at 1/3 years after discharge
Malignant arrythmiaOne year/Three year/Five yearVentricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
Worsening heart failureOne year/Three year/Five yearWorsen 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.
RNA/micro RNA/long-noncoding RNA-sequencing dataThe 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 sampleThe data is collected from lab in an average of 6 month after the sample recruiting
Exon sequencing dataThe data is collected from lab in an average of 6 month after the sample recruiting
Result of echocardiography-Ejection FractionThree yearThe 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.
Result of echocardiography-Left Ventricular End Diastolic DiameterThree yearThe whole results of echocardiography report will be recorded. The indicate can reflect the size of heart and be used for determination of heart enlargement.
Result of echocardiography-E/A RatioThree yearThe whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.
All-cause deathOne year/Three year/Five yearThe data is collected during follow-up visit at 1/3/5 years after discharge

Countries

China

Contacts

Primary ContactJie Du, PhD
jiedubj@126.com
Backup ContactYulin Li, PhD
lyllyl_1111@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026