Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

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