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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04974372
Acronym
HT
Enrollment
1500
Registered
2021-07-23
Start date
2021-08-01
Completion date
2025-12-31
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
Wuhan Asia Heart Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Xie Mingxing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Using Image-Pro Plus 6.0 software to measure myocardial fibrosisthe measurement of myocardial fibrosis up to 1 year after heart transplantThe 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
All cause death after the inclusion of the studyAll cause death happened after inclusion of this study, up to 5 yearsAll cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records every year
Acute rejection after the inclusion of the studyAcute rejection happened after inclusion of this study, up to 5 yearsAcute 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
Cardiac allograft vasculopathy after the inclusion of the studyCardiac allograft vasculopathy happened after inclusion of this study, up to 5 yearsCardiac 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

Secondary

MeasureTime frameDescription
Major adverse cardiac events after the inclusion of the studyMajor adverse cardiac events happened after inclusion of this study,up to 5 yearsMajor 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

Contacts

Primary ContactLi Zhang, PhD
zli429@hust.edu.cn18907131488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026