Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Pölzl, G; Altenberger, J; Comín-Colet, J; Delgado, JF; Fedele, F; García-González, MJ; Gustafsson, F; Masip, J; Papp, Z; Störk, S; Ulmer, H; Maier, S; Vrtovec, B; Wikström, G; Zima, E; Bauer, A, , LeoDOR, Investigators.
Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period: The multinational randomized LeoDOR trial.
Eur J Heart Fail. 2023; 25(11): 2007-2017.
Doi: 10.1002/ejhf.3006
Web of Science
PubMed
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FullText_MUG
- Study Group Mitglieder der Med Uni Graz:
- Fruhwald Friedrich
- von Lewinski Dirk
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- Abstract:
- AIM: The LeoDOR trial explored the efficacy and safety of intermittent levosimendan therapy in the vulnerable phase following a hospitalization for acute heart failure (HF). METHODS AND RESULTS: In this prospective multicentre, double-blind, two-armed trial, patients with advanced HF were randomized 2:1 at the end of an index hospitalization for acute HF to intermittent levosimendan therapy or matching placebo for 12 weeks. All patients had left ventricular ejection fraction (LVEF) ≤30% during index hospitalization. Levosimendan was administered according to centre preference either as 6 h infusion at a rate of 0.2 μg/kg/min every 2 weeks, or as 24 h infusion at a rate of 0.1 μg/kg/min every 3 weeks. The primary efficacy assessment after 14 weeks was based on a global rank score consisting of three hierarchical groups. Secondary clinical endpoints included the composite risk of tiers 1 and 2 at 14 and 26 weeks, respectively. Due to the COVID-19 pandemic, the planned number of patients could not be recruited. The final modified intention-to-treat analysis included 145 patients (93 in the combined levosimendan arm, 52 in the placebo arm), which reduced the statistical power to detect a 20% risk reduction in the primary endpoint to 60%. Compared with placebo, intermittent levosimendan had no significant effect on the primary endpoint: the mean rank score was 72.55 for the levosimendan group versus 73.81 for the placebo group (p = 0.863). However, there was a signal towards a higher incidence of the individual clinical components of the primary endpoint in the levosimendan group versus the placebo group both after 14 weeks (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.12-7.68; p = 0.021) and 26 weeks (HR 1.64, 95% CI 0.87-3.11; p = 0.122). CONCLUSIONS: Among patients recently hospitalized with HF and reduced LVEF, intermittent levosimendan therapy did not improve post-hospitalization clinical stability.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Simendan - administration & dosage
- Heart Failure - drug therapy
- Cardiotonic Agents - therapeutic use
- Patient Discharge - administration & dosage
- Stroke Volume - administration & dosage
- Pandemics - administration & dosage
- Aftercare - administration & dosage
- Prospective Studies - administration & dosage
- Ventricular Function, Left - administration & dosage
- Treatment Outcome - administration & dosage
- Double-Blind Method - administration & dosage
- Find related publications in this database (Keywords)
- Levosimendan
- Acute heart failure
- Randomised controlled trial
- Hospitalization
- N-terminal pro-B-type natriuretic peptide
- Global rank endpoint