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NCT04964713 Clinical Trial

A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes

Diabetes Clinical Trial

Official title:
A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04964713
Other study ID # 2021 V1.0
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2031

Study information
Verified date July 2022
Source Wuhan Union Hospital, China
Contact Jing Wang, PhD
Phone 13397105628
Email 2419676@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

Description:

This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2300
Est. completion date December 31, 2031
Est. primary completion date December 31, 2031
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 79 Years
Eligibility Inclusion Criteria: people with T2DM according to the WHO 2006 criteria Exclusion Criteria: including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Xie Mingxing Guangdong Provincial People's Hospital, Henan Provincial People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Wuhan Asia Heart Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary major adverse cardiovascular events including myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure through study completion, an average of 6 year
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