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临床试验/NCT04023214
NCT04023214已完成不适用

Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2011年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Reactive hyperemia index (RHI)

研究概览

简要总结

This pilot study will compare endothelial function in patients with ADPKD with matched healthy volunteers and normotensive chronic kidney disease stage 1 & 2 patients. Patients will undergo a single assessment of endothelial function and measurement of plasma and urine levels of biomarkers of endothelial function.

详细描述

Following recruitment we will record the following baseline demographics; age, gender, smoking status, body mass index, medical history.

Participants will undergo a noninvasive vascular assessment, venepuncture and will provide a urine sample.This will be done during a single visit to the CRF.

Noninvasive vascular assessment will consist of:

  1. Peripheral Arterial Tonometry This will be measured using the EndoPAT system (Itamar Medical)

Endothelial shear stress flow stimulus will be provided by inflation of a blood pressure cuff around the upper non-dominant arm to suprasystolic pressure (but <300mmHg) for 5 minutes. Following release of the cuff the resulting digital microcirculation vasodilatory response to ischaemic hyperaemia, quantified as the pulse wave amplitude, will be monitored over 5 minutes. The peak pulse wave amplitude measured at 90-150s post cuff deflation relative to baseline will be indexed to the changes in the opposite arm to give the reactive hyperaemia index. This measure of endothelial function constitutes the outcome measure. 2. Blood Pressure Assessment Brachial artery blood pressure will be measured in the left arm in the supine position using an automated device (Dinamap) and in accordance with the clinical research facility SOP. 3. Blood samples and urine samples

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18yrs, <50yrs
  • Able to understand spoken/written English sufficiently to give informed consent and to take part in clinical assessment
  • Clinical diagnosis of ADPKD
  • eGFR >60ml/min/1.73m2

排除标准

  • No history of cardiovascular disease or hypertension
  • Not diabetic
  • Not smoking
  • Not breastfeeding
  • Not pregnant
  • Not taking any regular medication (except oral contraceptives)
  • No musculoskeletal conditions contraindicating inflation of a blood pressure cuff to suprasystolic pressures around the forearm (as part of EndoPAT measurements)
  • Not morbidly obese: BMI<35 (May contribute to endothelial dysfunction)
  • eGFR <60ml/min/1.73m2

结局指标

主要结局

Reactive hyperemia index (RHI)

时间窗: Baseline

EndoPAT values (Endoscore)

次要结局

  • Systolic and diastolic Blood pressure(Baseline)
  • Proteinuria(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

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