Food Supplementation After Heart Failure Hospitalization

Key Takeaways

• Food supplementation was associated with high delivery completion and retention, and fresh produce received higher acceptability ratings than medically tailored meals.
• No significant difference was observed in the prespecified 90-day heart failure readmission or emergency department outcome versus usual care.
• A broader hierarchical composite favored supplementation, while conditional delivery tied to health care engagement was not associated with fewer heart failure events.

Among 150 recently discharged patients with heart failure, 90-day food supplementation was feasible and well accepted but was not associated with improvement in the prespecified primary clinical outcome versus usual care.

This open-label factorial randomized clinical trial was conducted at two hospitals in Dallas, Texas, from April 2024 through October 2025. Patients were hospitalized for heart failure and enrolled within 14 days of discharge. Exclusions included prior heart transplant, left ventricular assist device, inotropic support at discharge, current meal-delivery enrollment, and inability to receive home delivery. Participants were randomized 1:1:1 to medically tailored meals, fresh produce, or usual care, and supplementation recipients underwent a second 1:1 randomization to conditional or unconditional delivery. Participants were followed for 12 weeks; the cohort included 150 people, median age 59.5 years, 60.7% male, median ejection fraction 35%, baseline median KCCQ-CSS 56.6, and food insecurity in 52.7%.

Implementation metrics showed high completion and retention during the supplementation period. Food delivery completion was 93.6%, and reported consumption adherence averaged 4.7 days per week for medically tailored meals and 5.5 days per week for fresh produce. Retention was 96.0% across the 12-week follow-up. Fresh produce had higher acceptability than medically tailored meals, with Net Promoter Scores of 8.6 versus 7.3 and P=.02. Two participants were withdrawn because of clinical deterioration, 1 died, and 6 were lost to follow-up, while all participants remained in the intention-to-treat analysis.

The primary clinical outcome was heart failure readmission or emergency department visits for heart failure over 90 days. No significant difference was observed between food supplementation and usual care. There were 23 events among 100 participants receiving supplementation and 9 among 50 receiving usual care, with an adjusted rate ratio of 1.09. The 95% CI was 0.49 to 2.43, and P=.83. The prespecified primary endpoint did not improve with supplementation.

The secondary hierarchical composite used a win-ratio framework that incorporated all-cause death, total heart failure hospitalizations or emergency department visits, and at least a 10-point KCCQ-CSS improvement. This measure favored food supplementation over usual care, with a win ratio of 1.21, a 95% CI of 1.14 to 1.29, and P<.001. Among participants receiving supplementation, conditional delivery tied to clinic attendance and medication fills was not associated with risk of heart failure events.

Overall, 90-day food supplementation after heart failure hospitalization was described as feasible and well accepted without improvement in the primary clinical outcome.