Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

February 15, 2023 updated by: Dao Wen Wang, Tongji Hospital
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chenze Li, MD candidate
  • Phone Number: 86-27-83663280
  • Email: lichenze@126.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospitalized patients with cardiomyopathy will be enrolled in this study

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death confirmed by death comfirmation or interview with the relatives
Time Frame: up to 24 months
Death from cardiovascular causes and any unknown death unless there was another certain cause
up to 24 months
Heart transplantation confirmed by medical record
Time Frame: up to 24 months
Heart transplantation within 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death confirmed by death comfirmation or interview with the relatives
Time Frame: up to 24 months
Any death at hospital or after discharge
up to 24 months
Heart failure recurring confirmed by medical record
Time Frame: up to 24 months
Recurrence of heart failure at hospital or after discharge
up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission because of cardiovascular diseases confirmed by medical record
Time Frame: up to 24 months
Readmission because of cardiovascular diseases within 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: Dao Wen Wang, Doctor, Tongji Hospital,Wuhan, Hubei, China, 430030

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2003

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 24, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-DM-GENE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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