Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Dobutamine; Simendan

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.