Effects of Eplerenone on Blood Pressure, Heart and Kidney in Elderly Hypertensive Early Stage Chronic Kidney Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The change of heart function confirmed by echocardiograph and plasma level of BNP
研究概览
简要总结
The purpose of this study is to determine whether eplerenone is effective in the treatment of blood pressure, heart function, renal function in elderly hypertensive stage1 (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) 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 and may induce aldosterone breakthrough that plays important roles for the development of CVD. Eplerenone, a selective aldosterone blocker, is effective against essential hypertension; however, little is known about the effects of eplerenone on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of eplerenone on heart and kidney functions in elderly hypertensive early stage (stage1 (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2)) 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 stage1(eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60- 89ml/min/1.73m2)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 eplerenone
- •Stage3(eGFR 30-60 ml/min/1.73m2),stage4(eGFR 15-30 ml/min/1.73m2)and stage5 (eGFR <15 ml/min/1.73m2) CKD patients
- •The patients who are receiving hemodialysis or peritoneal dialysis
- •The patients who are taking itraconazole, ritonavir and nelfinavir
- •The patients who are taking potassium-sparing diuretics and potassium supplement
- •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
Eplerenone
干预措施: Eplerenone (Drug)
结局指标
主要结局
The change of heart function confirmed by echocardiograph and plasma level of BNP
时间窗: 6 months
The change of renal function confirmed by eGFR and proteinuria.
时间窗: 6 months
次要结局
- The change of blood pressure(6 months)
- 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