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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.
García-González, Martín J; de Mora-Martín, Manuel; López-Fernández, Silvia; López-Díaz, Javier; Martínez-Sellés, Manuel; Romero-García, José; Cordero, Marco; Lara-Padrón, Antonio; Marrero-Rodríguez, Francisco; del Mar García-Saiz, M; Aldea-Perona, Ana.
Afiliación
  • García-González MJ; Department of Cardiology, Hospital Universitario de Canarias, Ctra. La Cuesta - Taco, Ofra s/n, 38320, San Cristóbal de La Laguna, Sta. Cruz de Tenerife, Spain, martinjgarciagonzalez@gmail.com.
Cardiovasc Drugs Ther ; 27(6): 573-9, 2013 Dec.
Article en En | MEDLINE | ID: mdl-23887741
BACKGROUND: Advanced 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: The 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.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Piridazinas / Cardiotónicos / Insuficiencia Cardíaca / Hospitalización / Hidrazonas Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Cardiovasc Drugs Ther Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2013 Tipo del documento: Article

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Piridazinas / Cardiotónicos / Insuficiencia Cardíaca / Hospitalización / Hidrazonas Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Cardiovasc Drugs Ther Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2013 Tipo del documento: Article