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

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, LAICA study investigators, Francisco Marrero-Rodríguez, Martín J García-González, Ana Aldea-Perona, Emilia González Sola, Ma del Mar García-Saiz, Patricia Rodríguez-Fortúnez, Geoffrey Yanes-Bowden, Alejandro Sánchez-Grande, Marco Cordero, Antonio Lara-Padrón, Antonio Barragán-Acea, Francisco Bosa-Ojeda, Juan Lacalzada-Almeida, Ignacio Laynez-Cerdeña, Tirso Virgos-Aller, Marina Bullejos-Molina, Inmaculada Rodríguez-Pedrosa, Manuel de Mora-Martín, Ana Ma González-González, Beatriz Pérez-Villardón, Silvia López-Fernández, Inmaculada Zafra, Javier López-Díaz, Amada Recio, Carolina de Álvaro, Manuel Martínez-Sellés, José Romero-García, Hans Paul Gaeper, Oscar González-Lorenzo, Pilar Ortiz, Gonzalo Martín Gorria, Gerad Torres-Cortada, Verónica Martínez-Fabra, Jose Luis Morales-Rull, 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, LAICA study investigators, Francisco Marrero-Rodríguez, Martín J García-González, Ana Aldea-Perona, Emilia González Sola, Ma del Mar García-Saiz, Patricia Rodríguez-Fortúnez, Geoffrey Yanes-Bowden, Alejandro Sánchez-Grande, Marco Cordero, Antonio Lara-Padrón, Antonio Barragán-Acea, Francisco Bosa-Ojeda, Juan Lacalzada-Almeida, Ignacio Laynez-Cerdeña, Tirso Virgos-Aller, Marina Bullejos-Molina, Inmaculada Rodríguez-Pedrosa, Manuel de Mora-Martín, Ana Ma González-González, Beatriz Pérez-Villardón, Silvia López-Fernández, Inmaculada Zafra, Javier López-Díaz, Amada Recio, Carolina de Álvaro, Manuel Martínez-Sellés, José Romero-García, Hans Paul Gaeper, Oscar González-Lorenzo, Pilar Ortiz, Gonzalo Martín Gorria, Gerad Torres-Cortada, Verónica Martínez-Fabra, Jose Luis Morales-Rull

Abstract

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.

Figures

Fig. 1
Fig. 1
Summary of study design protocol

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