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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Levosimendan

Clinical Trial Outcome Measures

Primary 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Collaborator
    • Orion Corporation, Orion Pharma
  • Overall Official(s)
    • Scott Krause, Study Director, Abbott

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