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Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

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ClinicalTrials.gov Identifier: NCT00348504
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : November 20, 2007
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Abbott

Brief Summary:
The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: levosimendan Drug: dobutamine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
Study Start Date : March 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. All-cause mortality in the 180 days following randomization.

Secondary Outcome Measures :
  1. All-cause mortality during the 31 days following randomization
  2. Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion
  3. Number of day alive and out of hospital (DAOH) during the 180 days following randomization
  4. Patient's evaluation of change in dyspnea at 24 hours following randomization
  5. Patient's evaluation of change in Global Assessment at 24 hours following randomization
  6. Cardiovascular mortality during the 180 days following randomization


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written, signed and dated informed consent
  • Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal [two years since last menstrual cycle], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential
  • Hospitalised patients with acutely decompensated heart failure
  • Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months
  • Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:

    • oliguria (mean urine output < 30 ml/h for at least 6 hours) and not a result of hypovolemia
    • dyspnoea at rest or mechanical ventilation for heart failure
    • haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)

Exclusion Criteria:

  • Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy
  • Weight ≥ 160 kg
  • Cardiac surgery within 30 days before screening
  • Stroke within 3 months before screening
  • Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
  • Heart rate persistently 130 bpm or greater at screening or at baseline
  • Serum potassium less than 3.5 mmol/l at screening
  • Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation
  • Hypersensitivity to levosimendan or dobutamine or any of their excipients
  • A history of Torsades de Pointes
  • Severe renal insufficiency (serum creatinine > 450 mmol/l [5.0 mg/dl]) or on dialysis
  • Significant hepatic impairment at discretion of the investigator
  • Acute bleeding
  • Severe anemia (haemoglobin < 8 g/dl) at screening
  • Septicaemia or septic shock
  • Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
  • Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
  • Administration of levosimendan within 30 days prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348504


Locations
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United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Orion Corporation, Orion Pharma
Investigators
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Study Director: Robert J Padley, M.D. Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00348504     History of Changes
Other Study ID Numbers: 3001077
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Simendan
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors