EUCTR2012-002627-15-ES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 aged 18 years and older or confirmed postmenopausal women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy. Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study. The lower age limit may be higher if legally requested in the participating country
- •- 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
相似试验
进行中（未招募）
1 期
Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 14.1Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-NOBayer HealthCare AG1,286
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Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 14.1Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-ITBayer HealthCare AG1,510
进行中（未招募）
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Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 16.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 16.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 16.0Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-GRBayer HealthCare AG1,510
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Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 17.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 17.0Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-DEBayer HealthCare AG1,510
进行中（未招募）
不适用
Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 16.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 16.1Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-LTBayer HealthCare AG1,510