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临床试验/NCT07205692
NCT07205692招募中不适用

Multimorbidity and Cardiovascular Risk Factors After Renal Transplant

University Hospitals of Derby and Burton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Multimorbidity

研究概览

简要总结

Who can participate? Any adults over the age of 18 who have received a kidney transplant at the research centre are eligible for recruitment within the first month after transplant What does the study involve? The study involves observing and gathering data to understand how the health of people who receive a kidney transplant changes over the first year.

In particular the investigators are interested in the risk factors for heart disease and stroke, and how these change over the first year of transplant. The investigators are also interested in multiple health conditions, and how these impact patients after transplant.

There are no interventions but there will be measurements of diagnoses, risk factors for heart disease and stroke, and assessments of physical fitness Blood pressure, BMI, routine blood tests as well as assessing muscle and fat changes, how fit patients are and what new health conditions they have.

What are the possible benefits and risks of participating? There is no active treatment or intervention, so there are no risks of benefits compared to normal care.

Where is the study run from? University Hospitals of Derby and Burton NHS trust, at the Royal Derby hospital Renal Department.

When is the study starting and how long is it expected to run for? The study is expected to start 1/9/2025 and run for 2 years. Who is funding the study? The only costs of the study are funding for the staff member running the study, who is funded by the NIHR as an academic research fellow Who is the main contact? Dr Samuel Strain, Samuel.strain@nottingham.ac.uk

详细描述

  1. BACKGROUND

At the end of 2022 39,874 adult patients in the UK were living with a kidney transplant, representing 56.2% of the population on kidney replacement therapy. Kidney transplant remains the gold standard of renal replacement therapy and confers benefits in survival and quality of life over dialysis2. Short term survival post-transplant is good, with 94% adjusted 5 year survival in the UK for a transplant from a living donor and 87% for a deceased donor from the most recent UK renal registry data1.

A high proportion of renal transplant patients have a high burden of comorbidities. Increasing multimorbidity has been shown in the general population to increase risk of premature death and hospital admissions and is associated with poorer function and greater economic costs. Much of the data in kidney transplant recipients focusses on comorbidity burden at time of transplant and the predictive use of this data for outcomes. There is little available data on the patterns and progression of multimorbidity for patients living with renal transplant. An assessment of the wider CKD cohort was undertaken using medical records and self reporting to understand multimorbidity, with a group of 176 transplant patients in the UK and showed that 92% had at least one comorbidity in addition to CKD. The most common comorbidity was hypertension (60.1%), followed by musculoskeletal conditions (40.9%) and then cardiovascular disease and diabetes. However, there is no data available, in this study or others, on the longitudinal development of comorbidities after transplant receipt. There is also no data available on the impact of multimorbidity on the quality of life of kidney transplant recipients. Although there is evidence for development of specific conditions, this has not been examined within the context of multiple long term health conditions.

There is no consensus on the measurement of multimorbidity, and no consensus on which comorbid conditions should be used in a count. Expert reviewers suggest the conditions used to define multimorbidity should be guided by health impact and may be tailored to a study population. No such work has taken place in the kidney transplant population.

A major comorbidity at time of transplantation and in post transplantation is cardiovascular disease and this is a major cause of death for patients with a renal transplant. Although the risk of adverse cardiovascular outcomes is decreased compared to patients on dialysis it is significantly increased compared to the general population. In addition, there is a high prevalence of both hypertension and diabetes within the transplant population. As well as these being common comorbidities to have at time transplant, patients commonly develop post-transplant diabetes. Alongside these factors, the risk of cardiovascular disease is also increased by raised BMI and lipid levels, which are commonly raised in renal transplant patients. The interaction between these risk factors and transplant specific factors such as immunosuppressive medication and post-transplant weight gain contribute to significant cardiovascular risk. There is no consensus on specific post-transplant treatment targets or interventions. Much of the evidence available for the timeline of development of cardiovascular risk factors is limited to retrospective cohort data and does not place cardiovascular disease within the context of multimorbidity6. In addition, much of the data predates current immunosuppression strategies and cardiovascular management strategies.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • Capable of giving informed consent
  • In receipt of a single organ renal transplant and being followed up by UHDB as the referring team.

排除标准

  • Graft failure before return to follow up

结局指标

主要结局

Multimorbidity

时间窗: One year after transplant

The changes from baseline to year one of multimorbidity in the one year post kidney transplantation as measured by a disease count.

次要结局

  • Blood pressure(One year)
  • Lipid levels(One year)
  • Weight(One year)
  • HbA1c(One year)
  • Qualitative interview(One year after transplant)
  • Skeletal muscle as assessed by bioimpedance in kg(One year after transplant)
  • Body fat as measured by bioimpedance as percent body fat (the proportion of total body weight that is fat)(One year)
  • Kidney Disease Quality of Life Instrument (KDQOL)- 36(Over one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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