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临床试验/NCT02209402
NCT02209402
已完成
不适用

Effect of a 3-month Aerobic Training Program on Endothelial Function in Mild-to-moderate CKD: a Randomized Controlled Trial

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 40 人2012年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Kidney Disease
发起方
Universiteit Antwerpen
入组人数
40
试验地点
1
主要终点
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
状态
已完成
最后更新
11年前

概览

简要总结

Chronic kidney disease (CKD) is a prevalent disorder and a major health concern. Cardiovascular disease is the most prevailing and life-threatening complication observed in patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are more likely to occur than the evolution to final stages of kidney disease with the need for dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not affect cardiovascular prognosis in CKD, which suggests that the missing link between these two entities has not been elucidated yet.

In the present project, the investigators focus on endothelial dysfunction in patients with CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the absence of structural changes, endothelial dysfunction is still reversible, which offers therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.

The purpose of this study is to determine whether an exercise training program is effective in ameliorating endothelial dysfunction in patients with chronic kidney disease.

注册库
clinicaltrials.gov
开始日期
2012年4月
结束日期
2014年5月
最后更新
11年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Amaryllis Van Craenenbroeck

Dr.

Universiteit Antwerpen

入排标准

入选标准

  • patients with CKD stage 3-4 (eGFR (15-59 ml/min/1.73m2) without cardiovascular disease.

排除标准

  • patients \< 18 years
  • pregnancy
  • warfarin therapy
  • glucocorticoid therapy
  • clinically active malignant disease
  • heart failure (ejection fraction \< 50%)
  • peripheral vascular disease, defined as a history of intermittent claudication, abnormal peripheral angiography or Doppler ultrasound, lower limb artery bypass surgery/angioplasty/stenting or non-traumatic lower extremity amputation
  • cerebrovascular disease, defined as a history of transient ischemic attack (TIA) or stroke, significant stenosis of the A. carotis on ultrasound/CT angiography or carotid endarterectomy/stenting
  • coronary artery disease (CAD), defined as a history of myocardial infarction, coronary artery angioplasty/stenting/bypass surgery, significant structural coronary lesions on angiography or high suspicion of CAD on a maximal exercise test

结局指标

主要结局

Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)

时间窗: 3 months

次要结局

  • change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity(3 months)
  • change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness(3 months)
  • change in augmentation index (%) as a marker of arterial stiffness(3 months)
  • change in Intima Media Thickness (µm) of the right common carotid artery(3 months)

研究点 (1)

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