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临床试验/NCT03729557
NCT03729557进行中(未招募)不适用

Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
109
试验地点
1
主要终点
Change in left ventricular mass.

研究概览

简要总结

Chronic kidney disease (CKD) is highly frequent, and patients with advanced CKD are known to have a high risk of developing cardiovascular disease (CVD). However, little is known about the cardiovascular risk in patients with mildly reduced kidney function (reduced glomerular filtration rate, GFR), affecting up to 10% of the general population; and importantly, also affecting living kidney donors. Until recently it has been believed that donating a kidney does not represent any health hazard. However, a recent Norwegian epidemiological study suggested that kidney donors have an increased risk of CVD. The pathogenesis linking reduced kidney function to CVD is not known. Living kidney donors provide a unique model for investigating the mechanisms underlying increased risk of CVD in patients with reduced GFR because living kidney donors are healthy before donation. Thus, the main purpose of the Project is to investigate the mekanismes underlying the development of cardiovascular remodelling induced by a reduction in GFR.

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

  • 未提供

排除标准

  • Persons who do not meet the Norwegian donor criteria.

结局指标

主要结局

Change in left ventricular mass.

时间窗: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.

Cardiac magnetic resonance imaging (CMRI) and echocardiography.

Change in left ventricular strain.

时间窗: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.

CMRI and echocardiography.

次要结局

  • Change in the calsium/phosphate homeostasis.(Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.)
  • Change in inflammation-marker.(Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.)
  • Change in arterial pulse wave velocity.(Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.)
  • Change in intima and media thickness of aorta.(Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon Arne Birkeland

Principal investigator, Medical doctor, PhD

Oslo University Hospital

研究点 (1)

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