Abstract
OBJECTIVE: To evaluate the efficacy and safety of levosimendan in acute heart failure (AHF) patients with different body mass index (BMI) using real-world data. METHODS: This retrospective study enrolled 2,398 AHF patients hospitalized at 14 provincial, municipal, and county-level hospitals in Jiangxi Province from March 1, 2023, to March 1, 2025. After excluding 828 cases due to missing data and 60 cases with BMI < 18.5 kg/m(2), a total of 1,530 patients were included. Patients treated with levosimendan were categorized into three groups: normal weight group (18.5 ≤ BMI < 24, n = 535), overweight group (24 ≤ BMI < 28, n = 510), and obese group (BMI ≥ 28, n = 485). To assess the efficacy and safety of levosimendan in real-world AHF patients overall and across BMI groups, comparisons were made before and 7 days after treatment regarding heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), left ventricular ejection fraction (LVEF), NT-proBNP levels, cardiac function classification, respiratory symptoms, pulmonary rales, and adverse reactions. RESULTS: After 7 days of levosimendan treatment, patients showed significant reductions in SBP and DBP compared to pre-treatment levels (P < 0.01). LVEF significantly increased (P < 0.01), and NT-proBNP levels significantly decreased (P < 0.01). Serum creatinine levels also significantly decreased (P < 0.01). Significant improvements were observed in cardiac function classification, respiratory symptoms, and pulmonary rales (all P < 0.01). No significant changes were found in heart rate, serum potassium, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) (all P > 0.05). Baseline NT-proBNP levels differed significantly among the three groups (normal > overweight > obese, P < 0.01), a pattern that persisted after 7 days of treatment (P < 0.01). However, there were no significant differences among the groups in the magnitude of NT-proBNP reduction or the proportion of patients achieving a ≥ 30% reduction in NT-proBNP (P > 0.05). Compared to the normal weight group, the overweight and obese groups showed significantly greater increases in LVEF after treatment (P < 0.01), with the obese group showing a significantly greater increase than the overweight group (P < 0.01). The rates of improvement in cardiac function classification and respiratory symptoms were significantly higher in the overweight and obese groups compared to the normal weight group (P < 0.01). Although the obese group had slightly higher improvement rates than the overweight group, the difference was not statistically significant (P > 0.05). The incidence of hypotension was significantly lower in the overweight and obese groups compared to the normal weight group (P < 0.01). The total incidence of adverse reactions was also significantly lower in the overweight and obese groups (P < 0.01). Hospital length of stay was significantly shorter in the overweight and obese groups compared to the normal weight group (P < 0.05). There were no significant differences among the three groups in heart rate, SBP, DBP, pulmonary rales, serum potassium, ALT, AST, serum creatinine, or other adverse reactions after 7 days of treatment (all P > 0.05). CONCLUSIONS: 1. In patients with acute heart failure, levosimendan administration was associated with a decreasing trend in plasma NT-proBNP levels, an improvement in left ventricular ejection fraction, and alleviation of cardiac functional impairment and respiratory symptoms. Favorable safety profiles were generally observed during the treatment period. 2. Body mass index showed a negative correlation with NT-proBNP levels, suggesting that patients with higher BMI tend to have relatively lower baseline NT-proBNP levels. 3. In acute heart failure patients stratified by body mass index, levosimendan treatment exhibited between-group variations in clinical parameter improvements and safety profiles. Overweight and obese subgroups demonstrated a tendency toward more pronounced clinical improvement and fewer reported adverse events.