Efficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effects of a pulsed application of Levosimendan versus placebo on the composite end-point functional capacity and quality of life.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 both

• 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