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

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.