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.
Full Title of Study: “Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Drug: Levosimendan
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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,
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Overall Official(s)
- Scott Krause, Study Director, Abbott
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