Levosimendan for postoperative subclinical heart failure after noncardiac surgery: a randomized, double-blinded, phase III trial
摘要
The effect of Levosimendan on postoperative natriuretic peptides in noncardiac surgical patients remains unknown. Thus, this study evaluates the effect of a perioperative levosimendan administration on postoperative N-terminal brain pro natriuretic peptide (NT-proBNP) concentrations. In this prospective, double-blinded, parallel group, placebo-controlled, phase III trial 115 patients were assigned to perioperative single-dose of 12.5 mg of levosimendan and 115 to placebo between October 2020 through November 2023 (clinicaltrials.gov: NCT04329624). The primary outcome was postoperative maximum NT-proBNP concentration within the first 3 postoperative days. 228 patients completed the trial. Postoperative maximum NT-proBNP concentrations did not differ significantly between the groups (effect estimate: −64.51 ng.L-1; 95% CI −332.66 to 195.56; p = 0.61). Here, we show that perioperative levosimendan administration did not lead to a significantly lower release in postoperative NT-proBNP after noncardiac surgery.