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).