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

July 12, 2022 updated by: Xie Mingxing

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jing Wang, PhD
  • Phone Number: 13397105628
  • Email: 2419676@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xie Mingxing

Collaborators

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

Investigators

  • Principal Investigator: Jing Jing, PhD, Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

December 31, 2031

Study Completion (Anticipated)

December 31, 2031

Study Registration Dates

First Submitted

July 10, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021 V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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