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临床试验/NCT05073913
NCT05073913招募中不适用

Vascular Remodeling After Living Kidney Donation

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
2
主要终点
Carotid artery rigidity

研究概览

简要总结

Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. The object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. This approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. These results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. Of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • candidate to living kidney donation
  • affiliated to national health insurance
  • capable of understanding the consequences of participating to the study
  • written informed consent

排除标准

  • pregnancy
  • breastfeeding
  • allergy to iodinated contrast agents
  • allergy to echographic gel, allergy to cutaneous dressings
  • cutaneous lesions preventing the ultrasonography probe to be applied on the skin
  • participation to a drug trial

结局指标

主要结局

Carotid artery rigidity

时间窗: 1 year after living kidney donation or after the first exploration for the non donors

Carotid stiffness, as measured by echotracking

次要结局

  • Pulse wave velocity(1 year after living kidney donation or after the first exploration for the non donors)
  • Measured glomerular filtration rate(1 year after living kidney donation or after the first exploration for the non donors)
  • Endothelial function(1 year after living kidney donation or after the first exploration for the non donors)
  • Small arteries remodeling(1 year after living kidney donation or after the first exploration for the non donors)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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