EUCTR2008-007407-86-AT进行中（未招募）不适用
Efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III0 个研究点目标入组 120 人开始时间: 2009年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •- Patients with chronic stable heart failure NYHA III and IV diagnosed at least 3 months before inclusion
- •- 6-min.-walk-test < 350 meters
- •- EF < 35 %
- •- age > 20 years
- •- optimized and individualised neurohormonal background therapy according to ESC-guidelines for the treatment of chronic heart failure.
- •- Patient has signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Hospitalization for decompensated heart failure requiring i.v. diuretics within
- •the last month before randomization
- •?History of torsades des pointes
- •?Allergy to Levosimendan or any of the excipients
- •?Administration of inotropes in the last 4 weeks
- •?Potassium < 3,5 and >5,5 mmol/l
- •?Systolic blood pressure <= 100 mmHg
- •?Women at childbearing age without using effective contraceptives ( oral
- •contraceptives, intrauterine contraceptive devices) unless surgical sterilisation
- •has been undertaken.
- •? Female patients who are pregnant or nursing
- •?Creatinin Clearance < 30ml/min/m2
- •?Severe anemia (Hb < 10 mg /dl)
- •?Mechanical obstruction affecting the ventricular filling or the outflow or
- •?Patients with non compliance
- •?Severe conditions, which make the patient unsuitable to participate in a study as judged by the investigator
- •?Severe liver disease
- •?Percutaneous coronary intervention within the last 1 months
- •?Coronary bypass surgery within the last 3 months
- •?Planned HTX within the next six months
- •?Patient involved in another clinical trial
- •?De-nove heart failure
- •?Implantation of a cardiac resynchronisation device during the last three months
研究者
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