The Efficacy and Safety of Xinmailong Injection in Patients with Chronic Heart Failure: A Multicenter Randomized Double-Blind Placebo-Controlled Trial

Objectives: Chronic heart failure (CHF) is a chronic and progressive disease with high incidence. The aim of this study was to evaluate the effectiveness and safety of Xinmailong injection (XI) on CHF patients with B-type natriuretic peptide (BNP) >= 200 ng/mL and left ventricular ejection fraction (LVEF) of <= 45%. Trial design: This is a randomized double-blind placebo-controlled trial. Settings: Hospitals. Subjects: One hundred patients with CHF were randomly divided into XI (n = 50) and control groups (n = 50). Intervention: The XI group was treated with standard treatment plus XI (100 mg/2 mL, intravenous drip infusion). The control group was treated with standard treatment plus equal amounts of XI placebo. The course of treatment was 5 days. Outcome measures: New York Heart Association (NYHA) functional class, LVEF, BNP, and 6-min walking distance were assessed for therapeutic effect. Results: NYHA functional classes and LVEF were better in the XI group than in the control (p < 0.01). BNP was significantly different after the treatments in both groups (p < 0.01), and compared with the control, BNP was reduced after XI treatment (p < 0.01). No deaths occurred in the course of this study. The number of adverse events between the two groups was not statistically different (p > 0.05). Conclusions: XI can alleviate the symptoms, improve heart function, and exercise tolerance in patients with CHF and is safe to use.