NL-OMON40147已完成2 期
A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone versus eplerenone - ARTS-HF
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Men and women aged 18 years and older. The lower age limit may be higher if legally requested in the participating country
- •Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active. Adequate contraception is defined as a combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices)
- •Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital;• Subjects with clinical diagnosis of CHF either ischemic or non ischemic, NYHA functional class II -IV;• Subjects with type 2 diabetes mellitus ;and / or;Subjects with 30 mL/min/1.73m2 < or = eGFR < or = 60 mL/min/1.73m2 (MDRD)(23) at screening ;• Left ventricular ejection fraction (LVEF) < or = 40%;• Blood potassium <= 5.0 mmol/L at screening ;• Systolic blood pressure > or = 90 mmHg without signs and symptoms of hypotension at the screening visit
排除标准
- •Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis;• Acute coronary syndrome (ACS) in the last 30 days prior to screening ;• Cardiogenic shock;• Valvular heart disease requiring surgical intervention during the course of the study;• Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit;• Concomitant treatment with any MRA, renin inhibitor, or potassium-sparing diuretic
研究者
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