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.

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.

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 (+0.86cm vs–1.38cm; P=.006), and quality of life as measured by the Minnesota Living with HF Questionnaire (–7.95 vs–2.44; P=.028).

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.