Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy. This study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
Dept. Nephrology, Herlev Hospital
Herlev, Denmark
Herlev Hospital
Herlev, Denmark
Pulse wave velocity
Pulse wave velocity measured using the SphygmoCor device.
Time frame: 24 weeks
Pulse Wave velocity
Time frame: 12 weeks
Pulse wave velocity
Time frame: baseline
Ambulatory arterial stiffness index
24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.
Time frame: 24 weeks
Pulse wave analysis
Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.
Time frame: 24 weeks
Albuminuria
Will be calculated from 24 hour urine collections.
Time frame: baseline
Pulse wave analysis
Time frame: baseline
Ambulatory arterial stiffness index
Time frame: baseline
Ambulatory arterial stiffness index
Time frame: 12 weeks
Pulse wave analysis
Time frame: 12 weeks
Albuminuria
Time frame: 12 weeks
Albuminuria
Time frame: 24 weeks
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Time frame: baseline
Estimated glomerular filtration rate (eGFR)
Time frame: 12 weeks
Estimated glomerular filtration rate (eGFR)
Time frame: 24 weeks
Plasma potassium
Time frame: baseline
Plasma potassium
Time frame: week 1
Plasma potassium
Time frame: week 2
Plasma potassium
Time frame: week 4
Plasma potassium
Time frame: week 8
Plasma potassium
Time frame: week 12
Plasma potassium
Time frame: week 16
plasma potassium
Time frame: week 20
plasma potassium
Time frame: week 24
Blood pressure
BP will be measured at all visits
Time frame: baseline
Blood pressure
Time frame: 12 weeks
Blood pressure
Time frame: 24 weeks
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