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

NCT ID: NCT04974372

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-12-31

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.

Conditions

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Heart Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HT group

Patients have echocardiography examination before and after heart transplantation.

No interventions assigned to this group

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

No interventions assigned to this group

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xie Mingxing

OTHER

Sponsor Role lead

Responsible Party

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Xie Mingxing

Department of Ultrasound, Union Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ultrasound, Union Hospital, Wuhan, China

Central Contacts

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Li Zhang, PhD

Role: CONTACT

18907131488

Other Identifiers

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2021V1.0

Identifier Type: -

Identifier Source: org_study_id

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