Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients with heart failure who are malnourished.
OBJECTIVE
Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status. It is unknown whether a nutritional intervention can modify the prognosis of these patients. The aim of this study is to assess the efficacy of a nutritional intervention on morbidity and mortality in hospitalized patients with heart failure who are malnourished.


METHODS
PICNIC is a multicentre, randomized, controlled trial in which hospitalized patients with heart failure and malnutrition, as defined by the Mini Nutritional Assessment, are randomly assigned to conventional management of heart failure or conventional management of heart failure and an individualized nutritional intervention consisting of 3 points: optimization of diet, specific recommendations, and prescription, if deemed necessary, of nutritional supplements. A sample size of 182 patients for a maximum follow-up of 12 months has been estimated. The primary endpoint is time to death from any cause or rehospitalization because of heart failure. Analysis is by intention to treat.


CONCLUSIONS
PICNIC study will determine the prognostic impact of a nutritional intervention in hospitalized patients with heart failure who are malnourished.
Sección de Cardiología, Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.
Antonio L
AL
Gámez-López
Sección de Cardiología, Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain. Electronic address: jnlsbnll@hotmail.com.
Juan L
JL
Bonilla-Palomas
Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain.
Manuel
M
Anguita-Sánchez
Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.
Mirian
M
Moreno-Conde
Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.
Cristina
C
López-Ibáñez
Servicio de Endocrinología y Nutrición, Hospital Universitario Reina Sofía, Córdoba, Spain.
Rosa
R
Alhambra-Expósito
Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain.
Juan C
JC
Castillo-Domínguez
Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.
Antonia
A
Villar-Ráez
Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain.
José
J
Suárez de Lezo
D019587:Dietary Supplements; D006333:Heart Failure / Q000150:complications / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D044342:Malnutrition / Q000150:complications / Q000178:diet therapy*; D015596:Nutrition Assessment
Desnutrición; Heart failure; Insuficiencia cardiaca; Intervención nutricional; Malnutrition; Mini Nutritional Asessment; Nutritional intervention