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临床试验/NCT07301788
NCT07301788已完成不适用

A Mechanistic Study on the Impact of Donor Heart Procurement Time on Recipient Prognosis After Heart Transplantation Based on Multi-Omics Analysis

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The goal of this observational study is to learn about the impact of donor heart procurement time based on circadian rhythm on the long-term outcomes of heart transplant recipients. The main question it aims to answer is:

Does the time of day when a donor heart is procured-specifically during the circadian repression phase (00:00-12:00) versus the activation phase (12:00-00:00)-affect post-transplant survival and rejection rates in patients with end-stage heart failure?

Patients undergoing heart transplantation at the study hospital will have leftover donor heart tissue and preservation fluid collected during surgery for multi-omics analysis. These participants will then be followed prospectively for up to three years to track survival and rejection outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing heart transplantation surgery at our hospital due to end-stage heart failure.

排除标准

  • Exclude patients undergoing multi-organ combined transplantation, re-do heart transplantation, or those with a history of other organ transplantation.

结局指标

主要结局

Overall survival

时间窗: From date of transplantation up to 3 years post-transplant.

Post-heart-transplant survival assessed from the date of transplantation until death from any cause, evaluated through regular follow-up visits over the study period.

次要结局

  • Acute rejection rate(From date of transplantation up to 3 years post-transplant.)

研究者

发起方
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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