Status:
COMPLETED
Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure.
Detailed Description
Patients with decompensate heart failure (NYHA III-IV) and in need of intravenous inotrop support and who fulfil all inclusion and no exclusion criteria will be randomised into the study in proportion...
Eligibility Criteria
Inclusion
- Main
- Decompensated chronic heart failure of ischemic or non-ischemic origin, in NYHA class III to IV, despite optimised conventional treatment and who may benefit from intravenous positive inotropic agents as per the investigator's judgment.
- Ongoing treatment with a beta-receptor blocking agent in a stable regimen for at least 3 months and at an optimal dose as per the investigator's judgment.
- Left ventricular (LV) ejection fraction (EF) less than or similar to 35%.
- CI \< 2.5 l/min/m2.
- Mean PCWP \>15 mmHg.
- Main
Exclusion
- Significant mechanical obstruction affecting ventricular filling and/or outflow.
- Systolic blood pressure 85 mmHg or less at screening and/or baseline.
- Heart rate 130 bpm or greater, persistent for at least 5 minutes at screening and/or baseline.
- Severe angina pectoris during the 6 hours before screening and/or baseline.
- Deterioration of chronic heart failure due to an acute myocardial infarction within 5 days before screening measurements.
- Administration of Simdax within 1 month before baseline.
- A history of Torsades de Pointes.
- Evidence of severe renal insufficiency (serum creatinine \> 450 μmol/l or on dialysis) at screening.
- Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal range of the analysing laboratory at screening.
- Acute bleeding or severe anaemia.
- Heart surgery within 3 months before baseline.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00219388
Start Date
November 1 2002
End Date
April 1 2005
Last Update
March 20 2017
Active Locations (1)
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1
Cardiology Department, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45