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.

November 16, 2007 updated by: Abbott
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Abbott Park, Illinois, United States, 60064
        • Global Medical Information - Abbott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All-cause mortality in the 180 days following randomization.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Robert J Padley, M.D., Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 16, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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