ENdothelial DysfUnction in Renal Disease and Exercise Training

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Behavioral: Exercise Training

• Registration Number: NCT02209402
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-07-26
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise Training	-

Primary Outcome Measures

Name	Time	Method
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium