EUCTR2012-002627-15-NL进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 any 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
- •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%
- •Serum potassium < or = 5.0 mmol/L at screening
- •Systolic blood pressure > or = 90 mmHg without signs and symptoms of hypotension at the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1110
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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