Status:
COMPLETED
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.
Lead Sponsor:
Abbott
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT00348504
Start Date
March 1 2003
End Date
June 1 2005
Last Update
November 20 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064