Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

- A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age. - The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics. - It is allowable for the patients to be treated with IV inotropes and vasodilators.

The following criteria would exclude the patient from study: - invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization), - rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate), - severe ventricular outflow obstruction, - angina, - hypotension, - uncorrected hypokalemia, - CNS (e.g. stroke, TIA), - respiratory (e.g. COPD, intubated patients, oral, - intravenous or intramuscular steroids), - renal insufficiency (e.g. increased serum creatinine, dialysis), - hepatic impairment (e.g. significant increase in liver enzymes), - decompensation from active infection and acute bleeding (e.g. severe anemia). - Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions. - Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.