RT Journal Article
T1 Efficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial
A1 Comin-Colet, Josep
A1 Manito, Nicolas
A1 Segovia-Cubero, Javier
A1 Delgado, Juan
A1 Garcia Pinilla, Jose Manuel
A1 Almenar, Luis
A1 Crespo-Leiro, Maria G.
A1 Sionis, Alessandro
A1 Blasco, Teresa
A1 Pascual-Figal, Domingo
A1 Gonzalez-Vilchez, Francisco
A1 Luis Lambert-Rodriguez, Jose
A1 Grau, Maria
A1 Bruguera, Jordi
A1 LION-HEART Study Investigators, 
K1 Levosimendan
K1 Pulsed infusions
K1 Outpatient setting
K1 Advanced heart failure
K1 Safety
K1 Natriuretic peptides
K1 Clinical-evidence
K1 Management
AB 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.
PB Wiley
SN 1388-9842
YR 2018
FD 2018-07-01
LK http://hdl.handle.net/10668/14598
UL http://hdl.handle.net/10668/14598
LA en
DS RISalud
RD Apr 7, 2025