TY - JOUR
TI - Efficacy and safety of the pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep) study: A multicentre randomized trial
AU - Altenberger, J.
AU - Parissis, J.T.
AU - Costard-Jaeckle, A.
AU - Winter, A.
AU - Ebner, C.
AU - Karavidas, A.
AU - Sihorsch, K.
AU - Avgeropoulou, E.
AU - Weber, T.
AU - Dimopoulos, L.
AU - Ulmer, H.
AU - Poelzl, G.
JO - European Journal of Heart Failure
PY - 2014
VL - 16
TODO - 8
SP - 898-906
PB - John Wiley and Sons Ltd
SN - null
TODO - 10.1002/ejhf.118
TODO - levosimendan;  placebo;  cardiotonic agent;  hydrazone derivative;  pyridazine derivative;  simendan, aged;  article;  Austria;  controlled study;  double blind procedure;  drug dose reduction;  drug efficacy;  drug infusion;  drug safety;  event free survival;  female;  functional status;  Germany;  Greece;  heart atrium fibrillation;  heart death;  heart failure;  heart graft;  heart ventricle tachycardia;  human;  hypotension;  major clinical study;  male;  multicenter study;  multiple cycle treatment;  outpatient;  outpatient care;  priority journal;  quality of life;  questionnaire;  randomized controlled trial;  tachycardia;  ambulatory care;  clinical trial;  disease free survival;  heart failure;  intravenous drug administration;  middle aged;  severity of illness index;  treatment outcome;  very elderly, Aged;  Aged, 80 and over;  Ambulatory Care;  Cardiotonic Agents;  Disease-Free Survival;  Double-Blind Method;  Female;  Heart Failure;  Humans;  Hydrazones;  Infusions, Intravenous;  Male;  Middle Aged;  Pyridazines;  Quality of Life;  Severity of Illness Index;  Treatment Outcome
TODO - Aims The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity, quality of life, and event-free survival in patients with advanced heart failure. Methods and results This was a prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure (EF ≤35%, NYHA class III or IV). The study was conducted at 11 centres in Austria, Greece, and Germany. Levosimendan (0.2 μg/kg/min) or placebo was administered for 6 h at 2-week intervals over 6 weeks, in addition to standard care therapy. The primary outcome was the proportion of patients with a ≥20% improvement in the 6 min walk test and a ≥15% score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period. Secondary outcomes included event-free survival after 24 weeks. Analyses were performed on an intention-to-treat basis. The primary endpoint was reached in 19% of patients receiving levosimendan and 15.8% of patients receiving placebo (odds ratio 1.25; 95% confidence interval 0.44-3.59; P = 0.810). Cardiac death (four vs. one), heart transplants (two vs. one), and acute heart failure (14 vs. nine) were more frequent with placebo as compared with levosimendan. The incidence of side effects was comparable between groups. Conclusion Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo. An adequately powered, event-driven trial is warranted to enlarge on our findings. Trial registration: NCT01065194. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.
ER -