Heart Failure, Congestive
Conditions
Keywords
Decompensated chronic heart failure
Brief 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.
Interventions
DRUGLevosimendan
Sponsors
Orion Corporation, Orion Pharma
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion. | — |
Countries
Australia, Canada, Israel, United States
Outcome results
None listed