Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- reduction of left ventricular hypertrophy measured by magnetic resonance imaging
研究概览
简要总结
The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≧ 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent
排除标准
- •History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
- •Planned to taking percutaneous coronary intervention and coronary artery bypass graft
- •Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension.
- •History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months
- •Severe valvular heart disease or atrial fibrillation
- •Congenital heart disease
- •Severe heart failure (NYHA functional class Ⅳ)
- •Current treatment with aliskiren or eplerenone or diuretics
- •Taking potassium preparation or potassium-sparing diuretic
- •Estimated GFR ≦ 30ml/min/1.73m２ at screening or current treatment with hemodialysis
- •Potassium > 5.0mEq/L at screening
- •Diabetes mellitus with microalbuminuria or albuminuria
- •Impairment of liver function (liver failure, liver cirrhosis)
- •Pregnant woman or possibly pregnant woman
- •History of malignant tumor include hematological neoplasm
- •Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir
- •Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone
- •Current participation in another clinical trial
- •Serious non-cardiovascular disease severely limiting life expectancy
- •Contra-indication to MRI
研究组 & 干预措施
Aliskiren
Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers.
干预措施: Aliskiren (Drug)
Eplerenone
Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers
干预措施: Eplerenone (Drug)
结局指标
主要结局
reduction of left ventricular hypertrophy measured by magnetic resonance imaging
时间窗: 12 month
To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.
次要结局
- Cardiovascular events(12 month)
研究者
TOYOAKI MUROHARA
Professor of Medicine
Nagoya University