title: 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.
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.
authors.affiliation: 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.
authors.forename: Martín J
authors.initials: MJ
authors.lastname: García-González
authors.forename: Manuel
authors.initials: M
authors.lastname: de Mora-Martín
authors.forename: Silvia
authors.initials: S
authors.lastname: López-Fernández
authors.forename: Javier
authors.initials: J
authors.lastname: López-Díaz
authors.forename: Manuel
authors.initials: M
authors.lastname: Martínez-Sellés
authors.forename: José
authors.initials: J
authors.lastname: Romero-García
authors.forename: Marco
authors.initials: M
authors.lastname: Cordero
authors.forename: Antonio
authors.initials: A
authors.lastname: Lara-Padrón
authors.forename: Francisco
authors.initials: F
authors.lastname: Marrero-Rodríguez
authors.forename: M
authors.initials: M
authors.lastname: del Mar García-Saiz
authors.forename: Ana
authors.initials: A
authors.lastname: Aldea-Perona
mesh_terms: D002316:Cardiotonic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006333:Heart Failure / Q000188:drug therapy*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D006835:Hydrazones / Q000008:administration & dosage* / Q000009:adverse effects; D011724:Pyridazines / Q000008:administration & dosage* / Q000009:adverse effects; D000077464:Simendan
chemical_list: D002316:Cardiotonic Agents; D006835:Hydrazones; D011724:Pyridazines; D000077464:Simendan