Pharmacology of Immunosuppressants Following Heart Transplantation
2011年8月25日 更新者:Nigel E. Drury
Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation
The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ.
In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate.
However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood.
This varies due to genetic and other factors such as age, kidney function and the use of other drugs.
Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly.
However, some patients still experience episodes of rejection despite apparently acceptable levels.
In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells.
The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies.
This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.
研究概览
地位
未知
条件
研究类型
观察性的
注册 (预期的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Heart transplantation at the Queen Elizabeth Hosptial Birmingham.
描述
Inclusion Criteria:
- All patients undergoing heart transplantation
Exclusion Criteria:
- Decline participation
- Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
Post-heart transplant
All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of immunosuppressant drug levels in different compartments with evidence of rejection
大体时间:Multiple timepoints in first 12 months after transplantation
|
We will compare the levels of the drugs in different compartments of the body (in the blood, within white blood cells and within the heart muscle itself) with how well the drugs are working ie.
how well the heart is functioning and the level of rejection seen on routine heart biopsies.
Drug levels will be measured at C0 (trough) and C2 (peak).
|
Multiple timepoints in first 12 months after transplantation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments
大体时间:Multiple timepoints in first 12 months after transplantation
|
We will also compare these results with patient genetic and other factors (eg.
age, kidney function, use of other drugs) to better understand how these factors affect the levels of the drugs in different compartments of the body.
Drug levels will be measured at C0 (trough) and C2 (peak).
|
Multiple timepoints in first 12 months after transplantation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Robert S Bonser, MD FRCS、University Hospital Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年11月1日
研究注册日期
首次提交
2011年8月23日
首先提交符合 QC 标准的
2011年8月25日
首次发布 (估计)
2011年8月26日
研究记录更新
最后更新发布 (估计)
2011年8月26日
上次提交的符合 QC 标准的更新
2011年8月25日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.