Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pulse Wave velocity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Treatment
干预措施: Eplerenone (Drug)
结局指标
主要结局
Pulse Wave velocity
时间窗: 12 weeks
Pulse wave velocity
时间窗: baseline
次要结局
- Ambulatory arterial stiffness index(12 weeks)
- Albuminuria(24 weeks)
- Estimated glomerular filtration rate (eGFR)(24 weeks)
- Plasma potassium(week 16)
- plasma potassium(week 24)
- Blood pressure(24 weeks)
- Pulse wave analysis(12 weeks)
研究者
Lene Boesby
MD
Herlev Hospital