ENdothelial DysfUnction in Renal Disease and Exercise Training

Chronic Kidney Disease Clinical Trial

— Endure  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209402
• Other study ID #: EC/11/37/257
• Status: Completed
• Phase: N/A
• First received: July 26, 2014
• Last updated: August 4, 2014
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Exercise Training
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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in circulating endothelial progenitor cells (cells/1 million CD45+ events)		3 months	No
Other	change in migratory function of circulating angiogenic cells		3 months	No
Primary	Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)		3 months	No
Secondary	change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity		3 months	No
Secondary	change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness		3 months	No
Secondary	change in augmentation index (%) as a marker of arterial stiffness		3 months	No
Secondary	change in Intima Media Thickness (µm) of the right common carotid artery		3 months	No