• Martín J García-González, Manuel de Mora-Martín, Silvia López-Fernández, Javier López-Díaz, Manuel Martínez-Sellés, José Romero-García, Marco Cordero, Antonio Lara-Padrón, Francisco Marrero-Rodríguez, M del Mar García-Saiz, Ana Aldea-Perona, and LAICA study investigators.
• 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. 2013 Dec 1; 27 (6): 573-9.

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.

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