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

NCT03076580 | Unknown DMC

• 1 other identifier: BeijingIHLBVD2016031
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Age 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

• 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

• 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

Study Arms (3)

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.

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. 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.

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
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (3)

Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

RECRUITING

Beijing Institute of heart, lung and blood vessel diseases

Beijing, Beijing Municipality, China

RECRUITING

Shijie You

Beijing, China

ENROLLING BY INVITATION

Biospecimen

Retention: SAMPLES WITH DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.

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

• Jie Du, PhD

  Beijing Anzhen Hospital affiliated to Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jie Du, PhD

CONTACT

jiedubj@126.com

Yulin Li, PhD

CONTACT

lyllyl_1111@163.com

Study Design

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

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 10, 2017
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 31, 2021
• Last Updated: April 19, 2018

Record last verified: 2017-03

Locations

CN (3)