A Comparison of Haemodynamic Effects and Safety between DomesticLevosimendan versus Dobutamine for Hospitalized Patients with AcuteDecompensated Heart Failure

Aims: This study was a phase II trial of efficacy and safety of intravenous treatment with domestic levosimendan versus dobutamine in hospitalized patients with acute decompensated heart failure (ADHF). Methods and results: This was a multicentre, positive-controlled, prospective randomized open-label blinded study. A total of 228 ADHF patients from 8 medical centres were received 24 h intravenous domestic levosimendan (n=114) or dobutamine (n=114) therapy. SWAN-GANZ catheter was applied for patients with Pulmonary Capillary Wedge Pressure (PCWP) ≥ 15 mmHg and Cardiac Index (CI) ≤ 2.5 L/min/m2 (n=39 each). Compared with baseline level, left ventricular ejection fraction (LVEF) increased at 24 h in both groups (31.56% versus 28.44%, P 0.05). The change rate of PCWP at 24 h was remarkably greater in levosimendan group than in dobutamine group (-38.7% versus -23.9%, P<0.05). The change rate of NT-proBNP level at 3 days was also more remarkable in levosimendan group than in dubotamine group (-22.4% versus -8.6%, P<0.01). The incidences of adverse reactions and events were similar between two groups. Conclusion: In patients with ADHF, domestic levosimendan improved haemodynamic performance and NT-proBNP effectively than dobutamine. LVEF improvement was similar between domestic levosimendan and dobutamine. Tolerability and safety were similar between domestic levosimendan and dobutamine.