Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- The Change of Blood Pressure
研究概览
简要总结
The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Chronic kidney disease
- •Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
- •Elderly people(>=65 years old)
排除标准
- •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)
研究组 & 干预措施
Aliskiren
干预措施: Aliskiren (Drug)
结局指标
主要结局
The Change of Blood Pressure
时间窗: baseline and 6 month
The change of systolic blood pressure and diastolic blood pressure
The Change of Heart Function Confirmed by Echocardiograph
时间窗: baseline and 6 month
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.
The Change of BNP
时间窗: baseline and 6month
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
The Change of eGFR
时间窗: baseline and 6 month
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).
The Change of Urine Albumin/ Creatinine Ratio (UACR).
时间窗: baseline and 6 months
The UACR was measured at baseline, Week12 and Week24
次要结局
- The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM(6 months)
研究者
Yoshiyuki Morishita
MD. PhD
Jichi Medical University