ENdothelial DysfUnction in Renal Disease and Exercise Training (Endure)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
About this trial
This is an interventional prevention trial for 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
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Exercise Training
Arm Description
Outcomes
Primary Outcome Measures
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
Secondary Outcome Measures
change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity
change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness
change in augmentation index (%) as a marker of arterial stiffness
change in Intima Media Thickness (µm) of the right common carotid artery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209402
Brief Title
ENdothelial DysfUnction in Renal Disease and Exercise Training
Acronym
Endure
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
Exercise Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
Home-based training programme consisting of daily 4x10 minutes physical exercise on a magnetically braked bicycle at a heart rate corresponding to 80-90% of the heart rate achieved at the anaerobic threshold.
Primary Outcome Measure Information:
Title
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity
Time Frame
3 months
Title
change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness
Time Frame
3 months
Title
change in augmentation index (%) as a marker of arterial stiffness
Time Frame
3 months
Title
change in Intima Media Thickness (µm) of the right common carotid artery
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
change in circulating endothelial progenitor cells (cells/1 million CD45+ events)
Time Frame
3 months
Title
change in migratory function of circulating angiogenic cells
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
25960303
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.
Results Reference
derived
Learn more about this trial
ENdothelial DysfUnction in Renal Disease and Exercise Training
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