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dc.contributor.authorComin-Colet, Josep
dc.contributor.authorManito, Nicolas
dc.contributor.authorSegovia-Cubero, Javier
dc.contributor.authorDelgado, Juan
dc.contributor.authorGarcia Pinilla, Jose Manuel
dc.contributor.authorAlmenar, Luis
dc.contributor.authorCrespo-Leiro, Maria G.
dc.contributor.authorSionis, Alessandro
dc.contributor.authorBlasco, Teresa
dc.contributor.authorPascual-Figal, Domingo
dc.contributor.authorGonzalez-Vilchez, Francisco
dc.contributor.authorLuis Lambert-Rodriguez, Jose
dc.contributor.authorGrau, Maria
dc.contributor.authorBruguera, Jordi
dc.contributor.authorLION-HEART Study Investigators
dc.description.abstractAims 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, 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.
dc.subjectPulsed infusions
dc.subjectOutpatient setting
dc.subjectAdvanced heart failure
dc.subjectNatriuretic peptides
dc.titleEfficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial
dc.typeresearch article
dc.rights.accessRightsopen access
dc.contributor.authoraffiliation[Comin-Colet, Josep] Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain
dc.contributor.authoraffiliation[Bruguera, Jordi] Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain
dc.contributor.authoraffiliation[Comin-Colet, Josep] Univ Autonoma Barcelona, Barcelona, Spain
dc.contributor.authoraffiliation[Bruguera, Jordi] Univ Autonoma Barcelona, Barcelona, Spain
dc.contributor.authoraffiliation[Manito, Nicolas] Univ Barcelona, IDIBELL, Hosp Univ Bellvitge, Heart Dis Inst, Lhospitalet De Llobregat, Spain
dc.contributor.authoraffiliation[Segovia-Cubero, Javier] Hosp Univ Puerta Hierro, Madrid, Spain
dc.contributor.authoraffiliation[Delgado, Juan] Hosp 12 Octubre, Serv Cardiol, Unidad Insuficiencia Cardiaca & Trasplante, Madrid, Spain
dc.contributor.authoraffiliation[Garcia Pinilla, Jose Manuel] Hosp Univ Virgen Victoria, Malaga, Spain
dc.contributor.authoraffiliation[Almenar, Luis] Hosp Univ & Politecn La Fe, Valencia, Spain
dc.contributor.authoraffiliation[Crespo-Leiro, Maria G.] Univ A Coruna UDC, CHUAC, La Coruna, Spain
dc.contributor.authoraffiliation[Crespo-Leiro, Maria G.] Univ A Coruna UDC, Inst Invest Biomed A Coruna INIBIC, La Coruna, Spain
dc.contributor.authoraffiliation[Sionis, Alessandro] Univ Autonoma Barcelona, Biomed Res Inst IIB St Pau, Hosp Santa Creu & St Pau, Barcelona, Spain
dc.contributor.authoraffiliation[Blasco, Teresa] Hosp Univ Miguel Servet, Zaragoza, Spain
dc.contributor.authoraffiliation[Pascual-Figal, Domingo] Hosp Univ Virgen Arrixaca, Murcia, Spain
dc.contributor.authoraffiliation[Gonzalez-Vilchez, Francisco] Univ Cantabria, Hosp Univ Marques Valdecilla, Santander, Spain
dc.contributor.authoraffiliation[Luis Lambert-Rodriguez, Jose] Hosp Univ Cent Asturias, Unidad Trasplante Cardiaco & Insuficiencia Cardia, Oviedo, Spain
dc.contributor.authoraffiliation[Grau, Maria] Hosp Mar, Med Res Inst, IMIM, Cardiovasc Epidemiol & Genet, Barcelona, Spain
dc.contributor.authoraffiliation[Grau, Maria] Univ Barcelona, Barcelona, Spain
dc.contributor.funderOrion Pharma
dc.contributor.funderHospital del Mar Medical Research Institute (Barcelona, Spain)
dc.journal.titleEuropean journal of heart failure
dc.journal.titleabbreviationEur. j. heart fail.
dc.organizationHospital Universitario Virgen de la Victoria
Appears in Collections:Producción 2020

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