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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Transplant

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ALL adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography (TTE) for surveillance at their routine follow-up visits at our institution

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HT group; Patients have echocardiography examination before and after heart transplantation.
Control group; healthy volunteers who had no history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography were enrolled as control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2021V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No