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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

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.