75051 20200117221645.0 doi 10.1002/ejhf.1145 sideral 107477 ART-2018-107477 eng Comin-Colet, J. Efficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial 2018 Access copy available to the general public Unrestricted Aims: The LION-HEART study was a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial evaluating the efficacy and safety of intravenous administration of intermittent doses of levosimendan in outpatients with advanced chronic heart failure. Methods and results: Sixty-nine patients from 12 centres were randomly assigned at a 2: 1 ratio to levosimendan or placebo groups, receiving treatment by a 6-hour intravenous infusion (0.2 mu g/kg/min without bolus) every 2weeks for 12weeks. The primary endpoint was the effect on serum concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) throughout the treatment period in comparison with placebo. Secondary endpoints included evaluation of safety, clinical events and health-related quality of life (HRQoL). The area under the curve (AUC, pg.day/mL) of the levels of NT-proBNP over time for patients who received levosimendan was significantly lower than for the placebo group {344 x 10(3) [95% confidence interval (CI) 283 x 10(3)-404 x 10(3)] vs. 535 x 10(3) [443 x 10(3)-626 x 10(3)], P = 0.003}. In comparison with the placebo group, the patients on levosimendan experienced a reduction in the rate of heart failure hospitalisation (hazard ratio 0.25; 95% CI 0.11-0.56; P = 0.001). Patients on levosimendan were less likely to experience a clinically significant decline in HRQoL over time (P = 0.022). Adverse event rates were similar in the two treatment groups. Conclusions: In this small pilot study, intermittent administration of levosimendan to ambulatory patients with advanced systolic heart failure reduced plasma concentrations of NT-proBNP, worsening of HRQoL and hospitalisation for heart failure. The efficacy and safety of this intervention should be confirmed in larger trials. info:eu-repo/semantics/openAccess by-nc-nd http://creativecommons.org/licenses/by-nc-nd/3.0/es/ 13.965 2018 CARDIAC & CARDIOVASCULAR SYSTEMS 6 / 136 = 0.044 2018 Q1 T1 5.537 2018 Cardiology and Cardiovascular Medicine 2018 Q1 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Manito, N. Segovia-Cubero, J. Delgado, J. Pinilla, J.M.G. Almenar, L. Crespo-Leiro, M.G. Sionis, A. (orcid)0000-0002-1662-7057 Blasco, T. Universidad de Zaragoza Pascual-Figal, D. Gonzalez-Vilchez, F. Lambert-Rodriguez, J.L. Grau, M. Bruguera, J. 1007 610 Universidad de Zaragoza Dpto. Medicina, Psiqu. y Derm. Area Medicina 20, 7 (2018), 1128-1136 Eur. j. heart fail. European Journal of Heart Failure 1388-9842 438790 http://zaguan.unizar.es/record/75051/files/texto_completo.pdf Versión publicada 106357 http://zaguan.unizar.es/record/75051/files/texto_completo.jpg?subformat=icon icon Versión publicada oai:zaguan.unizar.es:75051 articulos driver 2020-01-17-22:06:22 ARTICLE