Heart TransplantHTNCT04974372
A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation
An observational study of Heart Transplant, run by Xie Mingxing.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Transplant
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- healthy volunteers
Who cannot join
- had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years
Secondary outcomes (1)
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
Measured: Major adverse cardiac events happened after inclusion of this study，up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xie Mingxing
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xie Mingxing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Li Zhang, PhD, Principal investigator, Department of Ultrasound, Union Hospital, Wuhan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974372
- Sponsor's protocol ID
- 2021V1.0
- Acronym
- HT
- Status last verified
- Jul 2021
- First submitted
- 10 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT04974372
- Acronym / sponsor ID
- HT / 2021V1.0
- Conditions
- Heart Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Xie MingxingUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Using Image-Pro Plus 6.0 software to measure myocardial fibrosis
Time frame: the measurement of myocardial fibrosis up to 1 year after heart transplant
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
All cause death after the inclusion of the study
Time frame: All cause death happened after inclusion of this study, up to 5 years
All 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 study
Time frame: Acute rejection happened after inclusion of this study, up to 5 years
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
Cardiac allograft vasculopathy after the inclusion of the study
Time frame: Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years
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
1 secondary outcome
Major adverse cardiac events after the inclusion of the study
Time frame: Major adverse cardiac events happened after inclusion of this study，up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, PhD principal investigator
Department of Ultrasound, Union Hospital, Wuhan, China
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by Xie Mingxing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, PhD (18907131488, zli429@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using Image-Pro Plus 6.0 software to measure myocardial fibrosis (time frame: the measurement of myocardial fibrosis up to 1 year after heart transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.