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2018-10-30

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cc-by-nc-nd (c) Pölzl, Gerhard et al., 2018
Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/174983

Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period

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https://doi.org/10.1002/ehf2.12366

Abstract

Hospitalization for acute heart failure (HF) is associated with a substantial morbidity burden and with associated healthcare costs and an increased mortality risk. However, few if any major medical innovations have been witnessed in this area in recent times. Levosimendan is a first-in-class calcium sensitizer and potassium channel opener indicated for the management of acute HF. Experience in several clinical studies has indicated that administration of intravenous levosimendan in intermittent cycles may reduce hospitalization and mortality rates in patients with advanced HF; however, none of those trials were designed or powered to give conclusive insights into that possibility. This paper describes the rationale and protocol of LeoDOR (levosimendan infusions for patients with advanced chronic heart failure), a randomized, double-blind, placebo-controlled, international, multicentre trial that will explore the efficacy and safety of intermittent levosimendan therapy, in addition to optimized standard therapy, in patients following hospitalization for acute HF. Salient features of LeoDOR include the use of two treatment regimens, in order to evaluate the effects of different schedules and doses of levosimendan during a 12 week treatment phase, and the use of a global rank primary endpoint, in which all patients are ranked across three hierarchical groups ranging from time to death or urgent heart transplantation or implantation of a ventricular assist device to time to rehospitalization and, lastly, time-averaged proportional change in N-terminal pro-brain natriuretic peptide. Secondary endpoints include changes in HF symptoms and functional status at 14 weeks.

Subject

Insuficiència cardíaca, Assaigs clínics, Factors de risc en les malalties, Malalts hospitalitzats

Subject (English)

Heart failure, Clinical trials, Risk factors in diseases, Hospital patients

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Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citation

PÖLZL, Gerhard, et al. Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period. ESC Heart Failure. 2018. Vol. 6, num. 1, pags. 174-181. ISSN 2055-5822. [consulted: 19 of August of 2026]. Available at: https://hdl.handle.net/2445/174983

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