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

This study has been completed.
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00048425
First received: October 31, 2002
Last updated: December 14, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Drug: Levosimendan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary 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.

Estimated Enrollment: 600
Study Start Date: September 2002
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048425

  Show 166 Study Locations
Sponsors and Collaborators
Abbott
Orion Corporation, Orion Pharma
Investigators
Study Director: Scott Krause Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00048425     History of Changes
Other Study ID Numbers: 3001069
Study First Received: October 31, 2002
Last Updated: December 14, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Decompensated chronic heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014