| October 31, 2002 |
| December 14, 2006 |
| September 2002 |
| |
| 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. |
| Same as current |
| Complete list of historical versions of study NCT00048425 on ClinicalTrials.gov Archive Site |
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| |
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| Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. |
| Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study. |
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. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Heart Failure, Congestive |
| Drug: Levosimendan |
| |
| |
| |
| Completed |
| 600 |
| December 2004 |
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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.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Canada, Israel |
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| NCT00048425 |
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| 3001069 |
| Abbott |
| Orion Corporation, Orion Pharma |
| Study Director: |
Scott Krause |
Abbott |
|
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| Abbott |
| December 2006 |