JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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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).

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