Nutritional intervention in acute heart failure patients with undernutrition and normalbuminemia: A subgroup analysis of PICNIC study.

BACKGROUND & AIMS: Hypoalbuminemia is common in acute heart failure (HF) patients and has been associated with increased hospital mortality and long-term mortality. Undernutrition is a factor causing hypoalbuminemia. The PICNIC study results show that a nutritional intervention in undernourished acute HF patients reduces the risks of all-cause death and of readmission for HF. We aimed to investigate whether the efficacy of a nutritional intervention is consistent among the subgroups of patients with and without hypoalbuminemia. METHODS: In PICNIC study, a total of 120 malnourished hospitalized patients due to acute HF were randomized to conventional HF treatment or conventional HF treatment combined with an individualized nutritional intervention. The primary endpoint was a composite of all-cause death or readmission for worsening of HF, with a maximum follow-up of 12 months. In this post-hoc sub-analysis we assessed the interaction of the effects of a nutritional intervention among patients with and without hypoalbuminemia. Analysis was by intention to treat. RESULTS: 59 (49,2%) patients demonstrated hypoalbuminemia and 61 (50,8%) had normalbuminemia. At 12 months, the number of events for the primary endpoint in the intervention group compared with the control group was consistent among patients with hypoalbuminemia (28.6% intervention vs 61.3% control, HR 0,35, 95% CI 0,15-0,81) and those without (25.8% intervention vs 60% control, HR 0,35, 95% CI 0,15-0,79; interaction p = 0,86). CONCLUSION: There was no evidence that the relative efficacy of a nutritional intervention in undernourished acute HF patients was different between patients with normalbuminemia and those with hypoalbuminemia.

Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure.

BACKGROUND AND AIMS: Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status. We undertook this study to assess whether a nutritional intervention in malnourished hospitalized patients with heart failure benefits morbidity and mortality. METHODS: A multicenter, randomized, controlled clinical trial was conducted. A total of 120 malnourished hospitalized patients due to acute heart failure were randomised to conventional heart failure treatment or conventional heart failure treatment combined with an individualized nutritional intervention. The primary endpoint of this study was a composite of all-cause death or readmission for worsening of HF, with a maximum follow-up of 12 months. Analysis was by intention to treat. RESULTS: Recruitment was stopped early according to the study protocol after completing the follow-up of the first 120 patients enrolled (59 in the intervention group and 61 in the control group). Both groups were homogeneous in baseline characteristics. At 12 months, the primary outcome occurred in 27.1% of patients in the intervention group and in 60.7% of patients in the control group (hazard ratio 0.45; 95% confidence interval [CI], 0.19-0.62, p = 0.0004). In total, 20.3% of patients died in the intervention group and 47.5% in the control group (hazard ratio 0.37, 95% CI, 0.19-0.72, p = 0.003). Readmission due to heart failure was also lower in the intervention group (10.2 vs. 36.1%, p = 0.001). CONCLUSION: Nutritional intervention in malnourished hospitalized patients with heart failure reduces the risk of death from any cause and the risk of readmission for worsening of heart failure (ClinicalTrial.govNCT01472237).

Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients with heart failure who are malnourished.

INTRODUCTION AND OBJECTIVES: 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.

Justificación y diseño del estudio PICNIC: Programa de Intervención Nutricional en pacientes hospitalizados por Insuficiencia Cardiaca desnutridos / Rationale and Design of PICNIC Study: Nutritional Intervention Program in Hospitalized Patients With Heart Failure Who Are Malnourished

Introducción y objetivos: Los pacientes hospitalizados por insuficiencia cardiaca en estado de desnutrición tienen un pronóstico más desfavorable que los que están en adecuado estado nutricional. Se desconoce si una intervención nutricional puede modificar el pronóstico de estos pacientes. El objetivo de este estudio es evaluar si una intervención nutricional sobre pacientes hospitalizados con insuficiencia cardiaca desnutridos produce beneficio en su morbimortalidad. Métodos: PICNIC es un ensayo clínico multicéntrico, aleatorizado y controlado, en el que se asigna aleatoriamente a los pacientes hospitalizados por insuficiencia cardiaca aguda que además estén en estado de desnutrición, definido según la puntuación de la encuesta Mini Nutritional Assessment, a tratamiento convencional de la insuficiencia cardiaca o a tratamiento convencional de la insuficiencia cardiaca más una intervención nutricional individualizada que consta de tres puntos: optimización de la dieta, recomendaciones específicas y prescripción, si se estima necesario, de suplementos nutricionales. Se ha estimado un tamaño muestral de 182 pacientes para un periodo máximo de seguimiento de 12 meses. La variable principal del estudio será el tiempo hasta la muerte por cualquier causa o reingreso por insuficiencia cardiaca. El análisis se realiza por intención de tratar. Conclusiones: El estudio PICNIC determinará el impacto pronóstico de una intervención nutricional en pacientes hospitalizados con insuficiencia cardiaca desnutridos (AU)

Introduction and objectives: 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 (AU)