Clinical trial NCT04974372: A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation
Official title: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Transplant
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Zhongshan Hospital
name: Henan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: Guangdong Provincial People's Hospital
First posted: 2021-07-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Using Image-Pro Plus 6.0 software to measure myocardial fibrosis
timeFrame: the measurement of myocardial fibrosis up to 1 year after heart transplant
measure: All cause death after the inclusion of the study
timeFrame: All cause death happened after inclusion of this study, up to 5 years
measure: Acute rejection after the inclusion of the study
timeFrame: Acute rejection happened after inclusion of this study, up to 5 years
measure: Cardiac allograft vasculopathy after the inclusion of the study
timeFrame: Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years
Secondary outcomes:
measure: Major adverse cardiac events after the inclusion of the study
timeFrame: Major adverse cardiac events happened after inclusion of this study，up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasound, Union Hospital, Wuhan, China
name: Li Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: