000075051 001__ 75051
000075051 005__ 20200117221645.0
000075051 0247_ $$2doi$$a10.1002/ejhf.1145
000075051 0248_ $$2sideral$$a107477
000075051 037__ $$aART-2018-107477
000075051 041__ $$aeng
000075051 100__ $$aComin-Colet, J.
000075051 245__ $$aEfficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial
000075051 260__ $$c2018
000075051 5060_ $$aAccess copy available to the general public$$fUnrestricted
000075051 5203_ $$aAims: 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.
000075051 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000075051 590__ $$a13.965$$b2018
000075051 591__ $$aCARDIAC & CARDIOVASCULAR SYSTEMS$$b6 / 136 = 0.044$$c2018$$dQ1$$eT1
000075051 592__ $$a5.537$$b2018
000075051 593__ $$aCardiology and Cardiovascular Medicine$$c2018$$dQ1
000075051 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000075051 700__ $$aManito, N.
000075051 700__ $$aSegovia-Cubero, J.
000075051 700__ $$aDelgado, J.
000075051 700__ $$aPinilla, J.M.G.
000075051 700__ $$aAlmenar, L.
000075051 700__ $$aCrespo-Leiro, M.G.
000075051 700__ $$aSionis, A.
000075051 700__ $$0(orcid)0000-0002-1662-7057$$aBlasco, T.$$uUniversidad de Zaragoza
000075051 700__ $$aPascual-Figal, D.
000075051 700__ $$aGonzalez-Vilchez, F.
000075051 700__ $$aLambert-Rodriguez, J.L.
000075051 700__ $$aGrau, M.
000075051 700__ $$aBruguera, J.
000075051 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000075051 773__ $$g20, 7 (2018), 1128-1136$$pEur. j. heart fail.$$tEuropean Journal of Heart Failure$$x1388-9842
000075051 8564_ $$s438790$$uhttps://zaguan.unizar.es/record/75051/files/texto_completo.pdf$$yVersión publicada
000075051 8564_ $$s106357$$uhttps://zaguan.unizar.es/record/75051/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000075051 909CO $$ooai:zaguan.unizar.es:75051$$particulos$$pdriver
000075051 951__ $$a2020-01-17-22:06:22
000075051 980__ $$aARTICLE