Clinical trial NCT02209402: ENdothelial DysfUnction in Renal Disease and Exercise Training
Official title: Effect of a 3-month Aerobic Training Program on Endothelial Function in Mild-to-moderate CKD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
timeFrame: 3 months
Secondary outcomes:
measure: change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity
timeFrame: 3 months
measure: change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness
timeFrame: 3 months
measure: change in augmentation index (%) as a marker of arterial stiffness
timeFrame: 3 months
measure: change in Intima Media Thickness (µm) of the right common carotid artery
timeFrame: 3 months
Other outcomes:
measure: change in circulating endothelial progenitor cells (cells/1 million CD45+ events)
timeFrame: 3 months
measure: change in migratory function of circulating angiogenic cells
timeFrame: 3 months
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
References:
citation: Van Craenenbroeck AH, Van Craenenbroeck EM, Van Ackeren K, Vrints CJ, Conraads VM, Verpooten GA, Kouidi E, Couttenye MM. Effect of Moderate Aerobic Exercise Training on Endothelial Function and Arterial Stiffness in CKD Stages 3-4: A Randomized Controlled Trial. Am J Kidney Dis. 2015 Aug;66(2):285-96. doi: 10.1053/j.ajkd.2015.03.015. Epub 2015 May 8.