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12月17日最近更新: 2013年4月1日

适应症

试验速览

暂无简介。

•- 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) yes
•F.1.3.1 Number of subjects for this age range

•?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

发起方

Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III