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临床试验/NCT03892343
NCT03892343Unknown不适用

A Prospective Study of the Effects of Renal Transplantation on Uraemic Cardiomyopathy Using Magnetic Resonance Imaging.

University Hospital Birmingham NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Left Ventricular Mass

研究概览

简要总结

Chronic kidney disease (CKD) is associated with a high risk of death and morbidity due to cardiovascular disease. Much of this is caused by left ventricular disease characterised by abnormal muscle thickness and scaring. This process appears to start early in the course of CKD and causes heart failure and dangerous abnormal heart rhythms. Previous work suggests that the process may be reversible by kidney transplantation but almost all of the studies are small, retrospective and lack scientific rigour. Furthermore, they almost all use echocardiography, which is inaccurate in patients with CKD. The investigators plan to perform the first large, prospective, controlled, blind-analysed study using cardiac magnetic resonance imaging to determine whether CKD associated cardiomyopathy is reversed by kidney transplantation and if so, whether factors such as blood pressure and mediators of metabolic bone disease/fibrosis are important in effecting this change. Greater understanding of the mechanisms responsible for CKD associated cardiomyopathy could lead to future strategies and treatments to improve the high cardiovascular mortality associated with this condition.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
  • Ages over 18 years
  • Exclusion Criteria
  • Non-standard anti-rejection treatment, post transplant.
  • Previous history of being unable to tolerate MRI scanner.
  • Contraindication to MRI - eg metal fragments in ey

排除标准

  • 未提供

结局指标

主要结局

Left Ventricular Mass

时间窗: One year.

Calculated by Cardiac MRI

次要结局

  • Pulse Wave Analysis.(One Year)
  • Native Myocardial T1 Times.(One year.)
  • Blood Pressure(One year.)

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Ferro, Dr

Professor Charles Ferro

University Hospital Birmingham NHS Foundation Trust

研究点 (1)

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