Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
研究概览
详细说明
Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.
The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Okayama
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Niimi、Okayama、日本、719-2643
- Niimi city Yukawa National health insurance clinic
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Tochigi
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Oyama、Tochigi、日本、329-0214
- Konan Hospital
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Sakura、Tochigi、日本、329-1395
- Kurosu Hospital
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Shimotsuke、Tochigi、日本、3290498
- Jichi Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of Chronic kidney disease
- Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
- Elderly people(>=65 years old)
Exclusion Criteria:
- The patients who are already taking aliskiren
- The patients who are receiving hemodialysis or peritoneal dialysis
- The patients who are taking cyclosporin
- The patients who have hyperkalemia(>=5.5mEq/ml)
- Severe heart failure (>=NYHA class III)
- Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (>=HbA1c 9.0&)
- Severe liver dysfunction (five folds increased AST or ALT than standard values)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:阿利吉仑
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150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The Change of Blood Pressure
大体时间:baseline and 6 month
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The change of systolic blood pressure and diastolic blood pressure
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baseline and 6 month
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The Change of Heart Function Confirmed by Echocardiograph
大体时间:baseline and 6 month
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Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month.
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
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baseline and 6 month
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The Change of BNP
大体时间:baseline and 6month
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Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
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baseline and 6month
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The Change of eGFR
大体时间:baseline and 6 month
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eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73
m2) = 194 × age-0.287
× serum creatinine-1.094
(multiplied by 0.739 for females).
|
baseline and 6 month
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The Change of Urine Albumin/ Creatinine Ratio (UACR).
大体时间:baseline and 6 months
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The UACR was measured at baseline, Week12 and Week24
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baseline and 6 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
大体时间:6 months
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6 months
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合作者和调查者
调查人员
- 首席研究员:Yoshiyuki Morishita, MD, PhD、Division of Nephrology, Department of Medicine, Jichi Medical University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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