Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure

Exclusion Criteria

• •1. Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy.
• •2. Predominantly right heart failure a/o severe tricuspid regurgitation
• •3. Cardiac surgery or coronary angioplasty within 30 days before study drug initiation.
• •4. Acute coronary syndrome within 30 days before study drug initiation.
• •5. Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
• •6. History of torsades de pointes
• •7. Stroke or transient ischaemic attack (TIA) within 3 months before study drug initiation
• •8. Systolic blood pressure less than 90 mmHg at baseline
• •9. Heart rate 120 bpm or greater at baseline
• •10. Serum potassium less than 3.5 mmol/l before study drug initiation.
• •11. Severe renal insufficiency (estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2)
• •12. Anaemia (haemoglobin \< 10 g/dl)
• •13. Significant hepatic impairment at the discretion of the investigator.
• •14. Hypersensitivity to levosimendan
• •15. Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer, end-stage lung disease)
• •16. Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
• •17. Administration of levosimendan within 14 days prior the study drug initiation, the first study drug application has to be postponed for at least 14 days after the end of this premedication
• •18. Suspected non-compliance
• •19. Pregnant woman and nursing mother
• •20. Failure to use highly-effective (Pearl Index lower than 1%) contraceptive methods.
• •21. Person with any kind of dependency on the investigator
• •22. Person held in an institution by legal or official order