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NCT05994274Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
8 Aug 2023
Start date
Dec 2023
Primary completion date
Dec 2027
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT number
NCT05994274

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From Dec 2023 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in any other clinical study within less than 30 days prior to screening date

Other illness

  • Another life-threatening disease with poor prognosis (survival less than 2 years)

Other

  • Refusal of the patient to provide consent
  • Suspected poor capability to follow instructions and cooperate

Who the study is looking for

  • After heart transplantation
  • Age ≥ 18
  • Disease duration: symptomatic heart failure ≥ 6 months prior to screening date
  • The patient's informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wuhan Union Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.