Food Supplementation in Patients Hospitalized for Heart Failure: A Randomized Clinical Trial.

Background

To determine the feasibility of providing food supplementation with medically tailored meals or fresh produce and explore the association of food supplementation vs usual care with clinical outcomes in patients recently hospitalized with HF and whether it differs by conditioning food supplementation to health care engagement.

确定提供医疗定制餐或新鲜农产品的食品补充的可行性，并探讨食品补充与常规护理相比在最近因HF住院的患者中的临床结果的关联，以及是否根据参与卫生保健的情况对食品补充进行条件化。

DESIGN, SETTING, AND PARTICIPANTS: This open-label factorial randomized clinical trial was conducted between April 2024 and October 2025 at 2 hospitals in Dallas, Texas.

设计、设置和参与者：这项开放标签的因子随机临床试验于2024年4月至2025年10月在德克萨斯州达拉斯的两家医院进行。

The study included patients who were hospitalized for HF and enrolled within 14 days of discharge, excluding those with prior heart transplant, a left ventricular assist device, or inotropic support at discharge; current enrollment in meal delivery programs; and inability to receive home deliveries.

研究包括在出院后14天内入院的HF患者，排除了既往接受过心脏移植、左心室辅助装置植入或出院时接受正性肌力支持的患者；目前参与餐食配送计划的患者；以及无法接受家庭配送的患者。

Participants were followed up with for 12 weeks.

参与者被随访了12周。

Of 150 participants enrolled, 2 were withdrawn due to clinical deterioration, 1 died, and 6 were lost to follow-up; all were included in the intention-to-treatanalysis.

在150名入组的参与者中，有2人因临床恶化被撤回，1人死亡，6人失访；所有这些人都被纳入了意向治疗分析。

Methods

Participants were randomized 1:1:1 to medically tailored meals, fresh produce, or usual care.

参与者被随机分为1:1:1，分别接受医学定制餐、新鲜农产品或常规护理。

Those receiving food supplementation underwent secondary 1:1 randomization to conditional (linked to clinic attendance and medication fills) vs unconditional delivery.

接受食物补充的参与者进行了二次1:1随机分配，分为条件性（与诊所出勤和药物填充相关）与无条件性配送。

main_outcomes_and_measures

Implementation outcomes included delivery completion, adherence, and acceptability and exploratory clinical outcomes.

实施结果包括完成交付、依从性和可接受性以及探索性的临床结果。

The primary clinical outcome was defined as readmission for HF or emergency department (ED) visits for HF over 90-day follow-up.

主要的临床结果被定义为在90天随访期间因心力衰竭导致的再次入院或急诊科（ED）就诊。

Secondary clinical outcomes included a win-ratio-based hierarchical composite (all-cause death, total HF hospitalizations or ED visits, and ≥10-point Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score [KCCQ-CSS] improvement).

次要临床结果包括基于胜率的层次复合指标（全因死亡、总心力衰竭住院或急诊就诊次数，以及≥10分的堪萨斯城心肌病问卷-临床总结评分[KCCQ-CSS]的改善）。

Results

Among 150 participants (median [IQR] age, 59.5 [52.0-66.0] years; 91 [60.7%] male), the baseline median (IQR) left ventricular ejection fraction was 35% (25.0-54.0), the baseline median (IQR) KCCQ-CSS was 56.6 (36.8-72.9), and 79 (52.7%) had food insecurity.

在150名参与者中（中位数[四分位数间距]年龄为59.5 [52.0-66.0]岁；91名[60.7%]为男性），基线中位数（四分位数间距）左心室射血分数为35%（25.0-54.0），基线中位数（四分位数间距）KCCQ-CSS为56.6（36.8-72.9），有79名（52.7%）存在食物不安全性。

Food delivery completion was 93.6% with a mean (SD) reported consumption adherence of 4.7 (2.4) days per week (medically tailored meals) and 5.5 (2.3) days per week (fresh produce), with high retention (96.0%).

食物配送完成率为93.6%，平均（标准差）报告的饮食依从性为每周4.7（2.4）天（针对医疗定制餐）和每周5.5（2.3）天（针对新鲜果蔬），且保持了高留存率（96.0%）。

Fresh produce demonstrated superior acceptability compared with medically tailored meals (Net Promoter Score: 8.6 vs 7.3; P = .02).

新鲜果蔬的接受度高于医疗定制餐（净推荐值：8.6比7.3；P = .02）。

There was no significant difference in the primary clinical outcome (HF readmission or ED visit) between food supplementation (23 events among 100 participants) vs usual care (9 events among 50 participants) (adjusted rate ratio, 1.09; 95% CI, 0.49-2.43; P = .83).

在主要临床结果（心力衰竭再入院或急诊就诊）上，食物补充（100名参与者中有23起事件）与常规护理（50名参与者中有9起事件）之间没有显著差异（调整后的比率比为1.09；95%置信区间为0.49-2.43；P = .83）。

The hierarchical composite favored food supplementation vs usual care (win ratio, 1.21; 95% CI, 1.14-1.29; P < .001).

层级复合结果更倾向于食物补充而非常规护理（胜率比为1.21；95%置信区间为1.14-1.29；P < .001）。

Among participants receiving food supplementation, conditional delivery (vs unconditional) was not associated with risk of HF events.

在参与食物补充的受试者中，条件性交付（与无条件性交付相比）与心力衰竭事件的风险无关。

conclusions_and_relevance

In this randomized clinical trial, 90-day food supplementation was feasible and well accepted in individuals with recent HF.

在这项随机临床试验中，90天的食物补充在近期心力衰竭的个体中是可行的，并且被良好接受。

Food supplementation was not associated with an improvement in the primary clinical outcome and there was no difference when conditioning food supplementation on health care engagement.

食物补充并未与主要临床结果的改善相关联，且在以医疗参与度为条件的食物补充中也未发现差异。

trial_registration

ClinicalTrials.gov Identifier: NCT06115369.

ClinicalTrials.gov 注册号：NCT06115369。