BACKGROUND We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure. METHODS Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals. RESULTS On-study retention at 12 weeks was 77% (82% versus 73%; P=0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%; P=0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both P<0.001; between-arms difference was 55 mmol (95% CI, 3-107; P=0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28]; P=0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm. CONCLUSIONS Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.

中文翻译：

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近期因心力衰竭住院的患者中的低钠盐饮食与中等钠盐饮食：PROHIBIT（通过限制钠盐预防心力衰竭的不良结果）试点研究。

背景我们进行了一项前瞻性研究，以评估高危患者中每日服用1500-3000毫克钠粉的12周喂养试验的可行性，研究保留率，利钠肽水平趋势，生活质量和安全性。心脏衰竭。方法196例因心力衰竭而刚入院（≤2周），射血分数≤40％，采用最佳药物治疗，功能独立且能够交流的患者中，有83例（47％）同意参加。其中27（年龄62±11岁；男性22；白人20；射血分数26±8％）的尿钠24小时≥3000 mg，并同意随机接受1500 mg（N = 12）或3000毫克（N = 15）钠粉。结果12周时的研究保留率为77％（82％对73％； P = 0.53）；6名患者（1500 mg中有2名，3000 mg组中有4名）退出研究之前。食物满意度问卷表明，两种饮食均耐受良好。1500 mg组在第12周的生活质量得到改善，但3000 mg组没有改变。进餐的平均依从性为52％（基于尿钠），两组之间无显着差异（42％对60％； P = 0.25）。研究餐使24小时尿钠减少137±21 mmol（1500 mg组）和82±16 mmol（3000 mg组），均P <0.001；臂间差异为55 mmol（95％CI，3-107; P = 0.037）。NT-proBNP（N端pro-B型利钠肽）不受影响。两组之间的住院和低血压事件无明显差异。在1500 mg组中，血清肌酐下降幅度更大（下降0.17 mg / dL [95％CI，0.06-0.28]； P = 0.003）。肌酐比基线增加> 0.5 mg / dL仅发生在3000 mg组的1名患者中。结论即使准备了饭菜，研究心力衰竭中的最佳饮食钠盐仍会带来挑战，包括需要进行广泛筛查，不愿参与和依从性问题。由于两种饮食均降低了尿钠含量而没有不利的安全性或生活质量的信号，因此一项较大的试验（进行改进以改善参与度和依从性）将是合乎道德和可行的。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02467296。进行修改以提高参与度和合规性将是合乎道德和可行的。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02467296。进行修改以提高参与度和合规性，这在道德上是可行的。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02467296。