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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04964713
Enrollment
2300
Registered
2021-07-16
Start date
2023-12-01
Completion date
2031-12-31
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Prognosis

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.

Detailed 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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
Wuhan Asia Heart Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Xie Mingxing
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
major adverse cardiovascular eventsthrough study completion, an average of 6 yearincluding myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure

Contacts

Primary ContactJing Wang, PhD
2419676@qq.com13397105628
Backup ContactLi Zhang, PhD
zli429@hust.edu.cn18907131488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026