A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation

Heart Transplant Clinical Trial

— HT  

Official title:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04974372
• Other study ID #: 2021V1.0
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2025

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
• Study type: Observational

Clinical Trial Summary

The aims of this study are to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection (AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.

Description:

This study will enrolled 1000 HT patients and 500 healthy controls, and the cardiac structure and function will be evaluated by ultrasound multimodal imaging. And the study aimed to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection(AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography

Related Conditions & MeSH terms

• Heart Transplant

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	Using Image-Pro Plus 6.0 software to measure myocardial fibrosis	The extent of myocardial fibrosis of the myocardial tissue from the removed heart during heart transplant was measured by Image-Pro Plus 6.0 software up to 1 year after heart transplant	the measurement of myocardial fibrosis up to 1 year after heart transplant
Primary	All cause death after the inclusion of the study	All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records every year	All cause death happened after inclusion of this study, up to 5 years
Primary	Acute rejection after the inclusion of the study	Acute rejection after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year	Acute rejection happened after inclusion of this study, up to 5 years
Primary	Cardiac allograft vasculopathy after the inclusion of the study	Cardiac allograft vasculopathy after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year	Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years
Secondary	Major adverse cardiac events after the inclusion of the study	Major adverse cardiac events after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year	Major adverse cardiac events happened after inclusion of this study,up to 5 years