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Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
This study has been completed.
Study NCT00048425   Information provided by Abbott
First Received: October 31, 2002   Last Updated: December 14, 2006   History of Changes

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
 
 
 
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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Heart Failure, Congestive
Drug: Levosimendan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
600
December 2004
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Israel
 
NCT00048425
 
3001069
Abbott
Orion Corporation, Orion Pharma
Study Director: Scott Krause Abbott
Abbott
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP