Metabolomic Study of All-age Cardiomyopathy

NCT03061994 | Unknown

• 1 other identifier: BeijingIHLBVD2016023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Result of echocardiography

  The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.

  three year

Secondary Outcomes (6)

• Cardiovascular death

  One year/Three year

• Re-hospitalization

  One year/Three year

• Heart transplantation

  One year/Three year

• malignant arrythmia

  One year/Three year

• Worsening heart failure

  These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting

Study Arms (2)

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.

Control

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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. age- and gender- mathced healthy controls are also recuitted in the hospital.

You may qualify if:

• Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
• Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures

You may not qualify if:

• Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
• History of rheumatic fever
• Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
• HIV infection or born to an HIV positive mother
• Kawasaki disease
• Immunologic disease
• Uremia, active or chronic
• Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia

Sponsors & Collaborators

• Beijing Institute of Heart, Lung and Blood Vessel Diseases: lead

Study Sites (1)

Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Restrictive

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities

Study Officials

• Yulin Li, PhD

  Beijing anzhen hospital affiliated to capital medical university

  STUDY DIRECTOR

• Yongqiang Lai, MD

  Beijing anzhen hospital affiliated to capital medical university

  STUDY DIRECTOR

Central Study Contacts

Jie Du, PhD

CONTACT

jiedubj@126.com

Hongzhao You

CONTACT

hongzhao_you@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 23, 2017
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: May 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)