Chronic Kidney Disease
Conditions
Keywords
aldosterone receptor inhibition, arterial stiffness, ambulatory arterial stiffness index
Brief summary
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.
Interventions
DRUGEplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
Sponsors
Rigshospitalet, Denmark
Lene Boesby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years age ≤ 80 years age * voluntarily signed informed consent * 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate \< 60 ml/min/1,73 m2 * BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment
Exclusion criteria
* p-potassium is \> 5.0 mM * allergy to contents * treated with spironolactone * treated with potent inhibitors of CYP3A4 (see SPC for details) * treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug * inborn errors of metabolism (see SPC for details) * pregnancy or lactation * fertile woman, not using safe contraception devices * dementia or other psychiatric disorder, making understanding of the study conditions impossible * other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement * vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries * systolic BP \> 200 mmHg * immeasurable pulse amplitude
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse wave velocity | 24 weeks | Pulse wave velocity measured using the SphygmoCor device. |
| Pulse Wave velocity | 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Albuminuria | baseline | Will be calculated from 24 hour urine collections. |
| Estimated glomerular filtration rate (eGFR) | baseline | Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. |
| Ambulatory arterial stiffness index | 24 weeks | 24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance. |
| plasma potassium | week 20 | — |
| Blood pressure | baseline | BP will be measured at all visits |
| Plasma potassium | baseline | — |
| Pulse wave analysis | 24 weeks | Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration. |
Countries
Denmark
Outcome results
None listed