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Clinical Trial
. 2025 Jul 1;16(1):5847.
doi: 10.1038/s41467-025-60601-y.

Levosimendan for postoperative subclinical heart failure after noncardiac surgery: a randomized, double-blinded, phase III trial

Christian Reiterer  1 , Barbara Kabon  2 , Alexander Taschner  1 , Alexandra Graf  3 , Nikolas Adamowitsch  1 , Katharina Horvath  1 , David Emler  1 , Oliver Zotti  1 , Nicole Hantakova  1 , Beatrix Hochreiter  4 , Melanie Fraunschiel  4 , Theresa Clement  5 , Edith Fleischmann  1
Affiliations
Clinical Trial

Levosimendan for postoperative subclinical heart failure after noncardiac surgery: a randomized, double-blinded, phase III trial

Christian Reiterer et al. Nat Commun. .

Abstract

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.

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Conflict of interest statement

Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Consort 2010 Flow Diagram.
Screening, enrollment and randomization of patients on the IMPROVE trial.
Fig. 2
Fig. 2. Postoperative time course and maximum NT-proBNP concentration.
Definition of boxplots: the median is shown as black bar, the box gives 25% and 75% percentiles, the Whiskers are chosen to extend up to 1.5 times the interquartile range from the box. Values outside this range are shown as dots. a Bloxplots are showing the perioperative time course of NT-proBNP within the first 3 days separately for the groups. b The violin plots show the distribution of maximum NT-proBNP concentrations within the first three postoperative days separately for the groups. The p value of the two-sided Wilcoxon-Rank-Sum test to compare treatment with placebo was 0.902.
Fig. 3
Fig. 3. Postoperative time course and maximum troponin T concentration.
Definition of boxplots: the median is shown as black bar, the box gives 25% and 75% percentiles, the Whiskers are chosen to extend up to 1.5 times the interquartile range from the box. Values outside this range are shown as dots. a Bloxplots are showing the perioperative time course of high-sensitive troponin T within the first 3 days separately for the groups. b The violin plots show the distribution of maximum high-sensitive troponin T concentrations within the first three postoperative days separately for the groups. The p value of the two-sided Wilcoxon-Rank-Sum test to compare treatment with placebo was 0.085.
See this image and copyright information in PMC

References

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