Nutritional intervention in older outpatients with chronic heart failure and malnutrition or at risk of malnutrition: the BOCADOS-IC randomized trial

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Abstract

INTRODUCTION AND OBJECTIVES: Heart failure (HF) is a growing public health concern, particularly among the elderly. Malnutrition is frequent in these patients and worsens prognosis. We aimed to determine the impact of a real-world, multidimensional nutritional program on major clinical outcomes and quality of life in older ambulatory patients with chronic HF who were malnourished or at risk of malnutrition. METHODS: This pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint trial enrolled outpatients aged > 65 years with chronic HF and a Mini Nutritional Assessment-Short Form (MNA-SF) score ≤ 11 from 14 Spanish hospitals. Participants were randomly assigned to either a structured nutritional strategy, comprising tailored dietary optimization and physical exercise recommendations, or usual care. The primary outcome was a 6-month composite of all-cause death or HF-related hospitalization. RESULTS: Recruitment was terminated early after enrolling 204 patients: 106 in the intervention group and 98 in the control group. At 6 months, no significant difference was observed in the primary composite endpoint between the intervention and control groups (17.9% vs 19.4%; HR, 0.90; 95%CI, 0.48-1.70). However, the intervention group showed significantly greater improvements in MNA-SF scores (+4.99 vs +3.65; P = .003), mid-arm muscle circumference (+0.86 cm vs -1.38 cm; P = .006), and quality of life as measured by the Minnesota Living with HF Questionnaire (-7.95 vs -2.44; P = .028). CONCLUSIONS: In elderly patients with chronic HF and malnutrition or at risk of malnutrition, a pragmatic nutritional intervention did not reduce major clinical outcomes. However, the intervention did improve nutritional status, biometric parameters, and quality of life. Achieving a reduction in clinical outcomes in this population may require more prolonged and individualized interventions. CLINICALTRIALS: gov number NCT05923138.

Abstract as published, via PubMed.