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A Clinical Study of Association Between Postoperative Dyslipidemia and Organ Rejection in Transplant Patients

A Prospective Clinical Study of Association Between Postoperative Dyslipidemia and Organ

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05994274
Enrollment
80
Registered
2023-08-16
Start date
2023-12-31
Completion date
2027-12-31
Last updated
2023-08-16

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

Conditions

Heart Transplant Failure and Rejection

Keywords

heart transplantation, Macrophages, Fatty acid, PCSK9, Lipid metabolism

Brief 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood lipid measurements4 yearsTG, TC, HDL-C, LDL-C, ApoB
Graft/Patient survival4 years

Secondary

MeasureTime frameDescription
Left ventricular ejection fraction (LVEF) at rest4 yearsdetermined by contrast echocardiography

Countries

China

Contacts

Primary ContactJiahong Xia
jiahong.xia@mail.hust.edu.cn(+0086)13971038472

Outcome results

None listed

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