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NCT Number: NCT04964713

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

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.

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Key information

Age range

35 year–79 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Wang, PhD

CONTACT

[email protected]

13397105628

Li Zhang, PhD

CONTACT

[email protected]

18907131488

Sponsors and collaborators

Lead sponsor

Xie Mingxing

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Jul 16, 2021
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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