Inclusion Criteria:
- Written, signed and dated informed consent
- Male and female patients over 18 years of age. Females of childbearing potential must
have a negative pregnancy test and must refrain from breastfeeding. Women who are
postmenopausal [two years since last menstrual cycle], surgically sterilised or who
have undergone a hysterectomy are considered not to be of childbearing potential
- Hospitalised patients with acutely decompensated heart failure
- Left ventricular ejection fraction less than or equal to 30 % as assessed using
echocardiography, radionuclide ventriculography or contrast angiography within 12
months
- Clinical need for intravenous inotropic support as evidenced by insufficient response
to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at
least one of the following at screening:
- oliguria (mean urine output < 30 ml/h for at least 6 hours) and not a result of
hypovolemia
- dyspnoea at rest or mechanical ventilation for heart failure
- haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP
≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)
Exclusion Criteria:
- 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
- Weight ≥ 160 kg
- Cardiac surgery within 30 days before screening
- Stroke within 3 months before screening
- Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
- Heart rate persistently 130 bpm or greater at screening or at baseline
- Serum potassium less than 3.5 mmol/l at screening
- Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone,
enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of
less than or equal than 2 mg/kg/min) during the current hospitalisation
- Hypersensitivity to levosimendan or dobutamine or any of their excipients
- A history of Torsades de Pointes
- Severe renal insufficiency (serum creatinine > 450 mmol/l [5.0 mg/dl]) or on dialysis
- Significant hepatic impairment at discretion of the investigator
- Acute bleeding
- Severe anemia (haemoglobin < 8 g/dl) at screening
- Septicaemia or septic shock
- Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
- 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 30 days prior to screening
