[Effect of omega-3 fatty acids on hypoalbuminemia in acute heart failure patients with increased inflammatory activity]. / Efecto de los ácidos grasos omega-3 sobre la hipoalbuminemia en pacientes con insuficiencia cardiaca aguda y actividad inflamatoria elevada.

INTRODUCTION: Introduction: inflammatory activity (IA) is a cause of hypoalbuminemia in patients with acute heart failure (AHF). Objectives: the main objective of this study was to evaluate whether an AI modulator treatment contributes to correcting albuminemia in this context. Methods: in this clinical trial 43 patients with AHF, hypoalbuminemia (serum albumin  3.4 g/dl), and elevated IA [C-reactive protein (CRP)  25 mg/l] were randomly assigned to receive omega-3 fatty acids (4 g daily) or placebo for 4 weeks. Albuminemia and CRP were reassessed at weeks 1 and 4. An analysis of variance for repeated measures was performed. Results: mean age was 75.6 ± 8.8 years, 72.1 % were male, and the most frequent etiology was ischemic (46.5 %). The two groups were homogeneous in their baseline characteristics. A significant increase in albumin concentration was found at week 4 from baseline (p for the effect of time < 0.001), with no differences between groups at week 1 or week 4. CRP decreased significantly in week 1 (p for the effect of time < 0.001), with no differences between groups in either week 1 or week 4. Conclusion: in patients with AHF, hypoalbuminemia, and elevated AI albuminemia normalizes in week 4, while CRP already drops significantly during the first week. In this context both effects are independent of the addition of high doses of omega-3 fatty acids.

INTRODUCCIÓN: Introducción: la actividad inflamatoria (AI) es causa de hipoalbuminemia en los pacientes con insuficiencia cardiaca aguda (ICA). Objetivos: el objetivo principal de este estudio fue evaluar si un tratamiento modulador de la AI contribuye a corregir la albuminemia en este contexto. Métodos: en este ensayo clínico, 43 pacientes con ICA, hipoalbuminemia (albúmina sérica ≤ 3,4 g/dl) y AI elevada [proteína C-reactiva (PCR)  25 mg/l] fueron asignados aleatoriamente a recibir ácidos grasos omega-3 (4 g diarios) o placebo durante 4 semanas. La albuminemia y la PCR se reevaluaron en las semanas 1 y 4. Se realizó un análisis de la varianza para medidas repetidas. Resultados: la edad media era de 75,6 ± 8,8 años, el 72,1 % eran varones y la etiología más frecuente era la isquémica (46,5 %). Los dos grupos fueron homogéneos en sus características basales. Se encontró un incremento significativo de la concentración de albúmina en la semana 4 con respecto a la basal (p del efecto tiempo < 0,001), sin que se hallaran diferencias entre los grupos ni en la semana 1 ni en la 4. La PCR descendió significativamente ya en la semana 1 (p del efecto tiempo < 0,001), sin que se encontraran diferencias entre los grupos ni en la semana 1 ni en la 4. Conclusión: en los pacientes con ICA, hipoalbuminemia y AI elevada, la albuminemia se normaliza en la semana 4 mientras que la PCR desciende significativamente en la primera semana. En este contexto, ambos efectos son independientes de la adición de altas dosis de ácidos grasos omega-3.

Has the clinical profile of patients with nonvalvular atrial fibrillation treated with rivaroxaban changed in the last 5 years of use?

AIM: To analyze the evolution of clinical profile of patients with nonvalvular atrial fibrillation treated with rivaroxaban. METHODS: Retrospective study in which patients treated with rivaroxaban were divided into two groups according to the data in which the initial prescription was performed (November 2012-December 2013 and January 2014-January 2017). RESULTS: 211 patients (mean age 76.7 ± 9.2 years; CHA2DS2-VASc 3.8 ± 1.5; HAS-BLED 2.0 ± 0.8.) were included. Age and bleeding risk were higher in those subjects in which the prescription started earlier. Rates of stroke/TIA, major bleeding and intracranial hemorrhage were 2.3/4.2/0.6 events/100 patient-years, respectively. CONCLUSION: Although, the initial prescription of rivaroxaban was mainly performed in very elderly patients and/or with a higher bleeding risk, this has been extended to the overall nonvalvular atrial fibrillation population.

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.

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.