NCT03754101

Brief Summary

Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2003

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

22.7 years

First QC Date

November 1, 2018

Last Update Submit

February 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular death confirmed by death comfirmation or interview with the relatives

    Death from cardiovascular causes and any unknown death unless there was another certain cause

    up to 24 months

  • Heart transplantation confirmed by medical record

    Heart transplantation within 24 months

    up to 24 months

Secondary Outcomes (2)

  • All cause death confirmed by death comfirmation or interview with the relatives

    up to 24 months

  • Heart failure recurring confirmed by medical record

    up to 24 months

Other Outcomes (1)

  • Readmission because of cardiovascular diseases confirmed by medical record

    up to 24 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients with cardiomyopathy will be enrolled in this study

You may qualify if:

  • · Patients diagnosed as cardiomyopathy according to the definition of American Heart Association

You may not qualify if:

  • Uncontrolled hypertension significant valvular disease
  • Mild ischemic heart disease
  • Significant systemic infection
  • Thyroid-induced cardiomyopathy
  • Excessive alcohol consumption
  • Precious cancer treatment including irradiation
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

  • Li S, Sun Y, Hu S, Hu D, Li C, Xiao L, Chen Y, Li H, Cui G, Wang DW. Genetic risk scores to predict the prognosis of chronic heart failure patients in Chinese Han. J Cell Mol Med. 2020 Jan;24(1):285-293. doi: 10.1111/jcmm.14722. Epub 2019 Oct 31.

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dao Wen Wang, Doctor

    Tongji Hospital,Wuhan, Hubei, China, 430030

    STUDY CHAIR

Central Study Contacts

Chenze Li, MD candidate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 27, 2018

Study Start

March 3, 2003

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations