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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05994274
Other study ID # WuhanUH-XJH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date December 2027

Study information

Verified date July 2023
Source Wuhan Union Hospital, China
Contact Jiahong Xia
Phone (+0086)13971038472
Email jiahong.xia@mail.hust.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Abnormal lipid metabolism is a common complication after organ transplantation, with pathological changes in lipid parameters occurring in approximately 60-80% of cardiac transplant recipients receiving triple immunotherapy with cyclosporine, imid azathioprine, and methylprednisolone. With the significant increase in long-term survival and increasing age of transplant patients, atherosclerotic cardiovascular diseases, such as those caused by dyslipidemia, have become a major cause of transplant organ failure and recipient death. However, the causes of dyslipidemia after organ transplantation, as well as the effects and mechanisms of dyslipidemia on transplant rejection, are unknown. Previous studies have found that 1. increased lipid levels occur in recipients after heart transplantation; 2. during rejection, hepatic PCSK9 expression is increased in recipients; 3. a high-fat environment increases the immunoreactivity of human peripheral blood lymphocytes. It is suggested that PCSK9-lipid disorder-immune cell interactions may be associated with the development of transplant rejection. In this project, we propose to (1) establish a long-term follow-up system for postoperative cardiac transplantation patients in our department to track the characteristics of lipid changes in transplantation patients, to clarify the link between dyslipidemia and rejection, and to provide a strong evidence-based medical basis for the management of lipids during the perioperative period and in the postoperative period; (2) expand the dimensions of lipid-related assays under the support of the above system, and to incorporate transcriptomic, proteomic, and metabolomic research methods to elucidate transplantation rejection in a multidimensional manner. (ii) Expanding the dimensions of lipid-related assays to include transcriptomic, proteomic, and metabolomic studies to elucidate the relationship between PCSK9 and dyslipidemia in transplant patients; (iii) Adopting single-cell sequencing technology to deeply reveal the potential mechanism by which changes in lipids affect T-cell-mediated rejection of cardiac transplants. The mechanism of T-cell-mediated cardiac transplantation rejection is revealed by single-cell sequencing.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - After heart transplantation - Age = 18 - Disease duration: symptomatic heart failure = 6 months prior to screening date - The patient's informed consent Exclusion Criteria: - Refusal of the patient to provide consent - Suspected poor capability to follow instructions and cooperate - Another life-threatening disease with poor prognosis (survival less than 2 years) - Participation in any other clinical study within less than 30 days prior to screening date

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Wuhan Union Hospital Wuhan

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood lipid measurements TG, TC, HDL-C, LDL-C, ApoB 4 years
Primary Graft/Patient survival 4 years
Secondary Left ventricular ejection fraction (LVEF) at rest determined by contrast echocardiography 4 years
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