Metabolomic Study of All-age Cardiomyopathy

NCT ID: NCT03061994

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-10-31

Brief Summary

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This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.

Detailed Description

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The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors,clinical lab data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled. Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiomyopathy

Children(older than 18 years old) are diagnosed as cardiomyopathy by three cardiologists and recruited in pediatric heart center,Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.

Adults are diagnosed as cardiomyopathy by three cardiologists and recruited in the department of cardiology ,Beijing Anzhen Hospital.

No interventions assigned to this group

Control

Healthy children and adults are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yulin Li, PhD

Role: STUDY_DIRECTOR

Beijing anzhen hospital affiliated to capital medical university

Yongqiang Lai, MD

Role: STUDY_DIRECTOR

Beijing anzhen hospital affiliated to capital medical university

Locations

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Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Du, PhD

Role: CONTACT

Hongzhao You

Role: CONTACT

Facility Contacts

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Jie Du, PhD

Role: primary

Yulin Li, PhD

Role: backup

Other Identifiers

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BeijingIHLBVD2016023

Identifier Type: -

Identifier Source: org_study_id

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