Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes

LeoDOR

Leitung: Prof. Dr. Michael Böhm

Ausgelaufene Studien

LeoDOR

Repetitive levosimendan infusions for patients with advanced chronic heart failure

CHF diagnosed at least 6 months before screening and treated with individually optimised long-term oral treatment for the last month
Left ventricular ejection fraction less than or equal to 30% within the index hospitalisation.
Currently hospitalised for decompensated HF requiring i.v. diuretics, or i.v. vasodilators, or i.v. inotropic therapy
Previous hospitalisation or visit to outpatient clinic requiring i.v. diuretics, i.v. vasodilators, or i.v. inotropic therapy, or their combination for acute decompensated HF within 12 months before the current hospitalisation.
NT-proBNP level after recompensation of ≥2500 ng/L (BNP ≥900 ng/L) and/or NYHA class III or IV at study entry

Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic obstructive cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy.
Predominantly right heart failure a/o severe tricuspid regurgitation
Cardiac surgery or coronary angioplasty within 30 days before study drug initiation.
Acute coronary syndrome within 30 days before study drug initiation.
Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
History of torsades de pointes
Stroke or transient ischaemic attack (TIA) within 3 months before study drug initiation
Systolic blood pressure less than 90 mmHg at baseline
Heart rate 120 bpm or greater at baseline
Serum potassium less than 3.5 mmol/l before study drug initiation.
Severe renal insufficiency (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m²)
Anaemia (haemoglobin < 10 g/dl)
Significant hepatic impairment at the discretion of the investigator.
Hypersensitivity to levosimendan
Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer, end-stage lung disease)
Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
Administration of levosimendan within 14 days prior the study drug initiation