A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes
1 other identifier
observational
2,300
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
July 13, 2022
July 1, 2022
8.1 years
July 10, 2021
July 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
major adverse cardiovascular events
including myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure
through study completion, an average of 6 year
Study Arms (3)
type 2 diabetes
T2DM was defined according to the WHO 2006 criteria. Assessing the left heart and right heart structure and function of T2DM by speckle tracking echocardiography.
Prediabetes
According to the WHO 2006 criteria, combining impaired fasting glucose and impaired glucose tolerance as prediabetes. Assessing the left heart and right heart structure and function of prediabetes by speckle tracking echocardiography.
normal glucose metabolism(NGM)
Assessing the left heart and right heart structure and function of NGM by speckle tracking echocardiography.
Eligibility Criteria
All patients with type 2 diabetes mellitus and prediabetes were diagnosed according to the WHO 2006 criteria, aged 35 -79 years, who are undergoing echocardiography examination in clinical needs.
You may qualify if:
- people with T2DM according to the WHO 2006 criteria
You may not qualify if:
- including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xie Mingxinglead
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Wuhan Asia Heart Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Jing, PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Department of Ultrasound, Union Hospital
Study Record Dates
First Submitted
July 10, 2021
First Posted
July 16, 2021
Study Start
December 1, 2023
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
July 13, 2022
Record last verified: 2022-07