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Not yet recruitingNCT04964713Updated Jul 13, 2022

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

An observational study in Diabetes and Prognosis, sponsored by Xie Mingxing. Not yet recruiting. Open to participants aged 35 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.

Sponsored by Xie Mingxing · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,300
Ages
35 Years to 79 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diabetes
  • Prognosis

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 2,300 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Xie Mingxing is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

Inclusion criteria

people with T2DM according to the WHO 2006 criteria

Exclusion criteria

Exclusion Criteria:

including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. major adverse cardiovascular events

    including myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure

    Time frame: through study completion, an average of 6 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04964713
Lead sponsor
Xie Mingxing
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
Responsible party
Xie Mingxing (Head of Department of Ultrasound, Union Hospital, Wuhan Union Hospital, China) — Sponsor-investigator
First posted
Jul 16, 2021
Start date
Dec 1, 2023 (estimated)
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Jul 13, 2022

Study contacts

Jing Wang, PhD
Contact
2419676@qq.com
13397105628
Li Zhang, PhD
Contact
zli429@hust.edu.cn
18907131488
Jing Jing, PhD
principal investigator · Wuhan Union Hospital, China
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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