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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.
This study has been completed.

First Received on June 30, 2006.   Last Updated on November 16, 2007   History of Changes
Sponsor: Abbott
Collaborator: Orion Corporation, Orion Pharma
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00348504
  Purpose

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 Intervention Phase
Acute Heart Failure
Drug: levosimendan
Drug: dobutamine
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Abbott:

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

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

Estimated Enrollment: 1300
Study Start Date: March 2003
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348504

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

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00348504     History of Changes
Other Study ID Numbers: 3001077
Study First Received: June 30, 2006
Last Updated: November 16, 2007
Health Authority: France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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
Anti-Arrhythmia Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012