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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Transplant

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HT group<br>Patients have echocardiography examination before and after heart transplantation. | |
| Control group<br>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?
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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 |