Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Safety, Efficacy, Levosimendan, Dobutamine, Intravenous, Invasive hemodynamics, Decompensated Heart Failure
Eligibility Criteria
Main Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Cardiology Department, Sahlgrenska University Hospital