Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

Cardiomyopathy Clinical Trial

Official title:

Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754101
• Other study ID #: TJ-DM-GENE
• Status: Recruiting
• Start date: March 3, 2003
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2023
• Source: Tongji Hospital
• Contact: Chenze Li, MD candidate
• Phone: 86-27-83663280
• Email: lichenze[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission because of cardiovascular diseases confirmed by medical record	Readmission because of cardiovascular diseases within 24 months	up to 24 months
Primary	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
Primary	Heart transplantation confirmed by medical record	Heart transplantation within 24 months	up to 24 months
Secondary	All cause death confirmed by death comfirmation or interview with the relatives	Any death at hospital or after discharge	up to 24 months
Secondary	Heart failure recurring confirmed by medical record	Recurrence of heart failure at hospital or after discharge	up to 24 months