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NCT04976517 Clinical Trial

Echocardiographic Assessment of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation

Heart Transplant Clinical Trial

Official title:
A Multicenter Clinical Study of Echocardiographic Evaluation of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04976517
Other study ID # 2021 v1.00
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date March 31, 2024

Study information
Verified date July 2021
Source Wuhan Union Hospital, China
Contact Li Zhang, PhD
Phone 18907131488
Email zli429@hust.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

Description:

This study is planed to enroll 300000 patients after heart transplantation, all the patients will be divided into 3 groups according to whether or not they have diabetes and when did they develop diabete. Echocardiography will be used to evaluat their cardiac function. Comparing their cardiac function and clinical information and analysing their prognosis to evaluat the impact of diabetes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1500
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients who received a heart transplant after 2015 Exclusion Criteria: - The image quality is poor

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Xie Mingxing 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

Outcome
Type Measure Description Time frame Safety issue
Primary all-cause mortality death from all causes up to 2023.12
Primary acute rejection acute rejection required treatment up to 2023.12
Primary readmission readmission from all causes up to 2023.12
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