RT Journal Article
T1 Rationale and design of a randomized, double-blind, placebo controlled multicenter trial to study efficacy, security, and long term effects of intermittent repeated levosimendan administration in patients with advanced heart failure: LAICA study.
A1 García-González, Martín J
A1 Mora-Martín, Manuel de
A1 López-Fernández, Silvia
A1 López-Díaz, Javier
A1 Martínez-Sellés, Manuel
A1 Romero-García, José
A1 Cordero, Marco
A1 Lara-Padrón, Antonio
A1 Marrero-Rodríguez, Francisco
A1 García-Saiz, M. del Mar
A1 Aldea-Perona, Ana
K1 Advanced heart failure
K1 Levosimendan
K1 Efficacy
K1 Safety
K1 Repeated administration
K1 Outpatients
K1 Insuficiencia cardíaca
K1 Resultado del tratamiento
K1 Pauta de administración medicamentosa
K1 Pacientes Ambulatorios
K1 Morbilidad
K1 Mortalidad
K1 Hospitalización
K1 Cardiotónicos
K1 Estudios multicéntricos como asunto
K1 Estudios prospectivos
K1 Ensayos clínicos controlados como asunto
AB BACKGROUNDAdvanced heart failure (HF) is associated with high morbidity and mortality; it represents a major burden for the health system. Episodes of acute decompensation requiring frequent and prolonged hospitalizations account for most HF-related expenditure. Inotropic drugs are frequently used during hospitalization, but rarely in out-patients. The LAICA clinical trial aims to evaluate the effectiveness and safety of monthly levosimendan infusion in patients with advanced HF to reduce the incidence of hospital admissions for acute HF decompensation.METHODSThe LAICA study is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group trial. It aims to recruit 213 out-patients, randomized to receive either a 24-h infusion of levosimendan at 0.1 μg/kg/min dose, without a loading dose, every 30 days, or placebo.RESULTSThe main objective is to assess the incidence of admission for acute HF worsening during 12 months. Secondarily, the trial will assess the effect of intermittent levosimendan on other variables, including the time in days from randomization to first admission for acute HF worsening, mortality and serious adverse events.CONCLUSIONSThe LAICA trial results could allow confirmation of the usefulness of intermittent levosimendan infusion in reducing the rate of hospitalization for HF worsening in advanced HF outpatients.
PB Springer Verlag
SN 0920-3206
YR 2013
FD 2013-12
LK http://hdl.handle.net/10668/1538
UL http://hdl.handle.net/10668/1538
LA en
NO García-González MJ, de Mora-Martín M, López-Fernández S, López-Díaz J, Martínez-Sellés M, Romero-García J, et al. Rationale and design of a randomized, double-blind, placebo controlled multicenter trial to study efficacy, security, and long term effects of intermittent repeated levosimendan administration in patients with advanced heart failure: LAICA study. Cardiovasc Drugs Ther. 2013                         ; 27(6):573-9
NO Journal Article; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 8, 2025