NCT00082589已完成4 期
A Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.54 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 54
- 主要终点
- Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
研究概览
简要总结
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III)
- •LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening
- •Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks
排除标准
- •Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening
- •Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
结局指标
主要结局
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
次要结局
未报告次要终点
研究者
研究点 (54)
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