Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial
Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial
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DOI：
10.1016/s0140-6736(22)00369-5
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发表时间：
2022-04-07
期刊：
影响因子：
168.9
通讯作者：
Zieroth, Shelley
中科院分区：
文献类型：
--
作者：
Ezekowitz, Justin A.;Colin-Ramirez, Eloisa;Zieroth, Shelley
研究背景：对于心力衰竭患者，建议限制钠饮食以防止体液超载和不良后果。我们设计了100 mmol以下的饮食干预心力衰竭（钠- hf）研究，以测试饮食钠的减少是否会降低未来临床事件的发生率。钠- hf是一项国际、开放标签、随机对照试验，在6个国家（澳大利亚、加拿大、智利、哥伦比亚、墨西哥和新西兰）的26个地点招募患者。符合条件的患者年龄在18岁或以上，患有慢性心力衰竭（纽约心脏协会[NYHA]功能分级2-3），并接受最佳耐受性指导的药物治疗。患者被随机分配（1:1），使用标准数字发生器和不同的分组大小为2、4或6，按地点分层，根据当地指南进行常规护理或低于100 mmol的低钠饮食(即，
Background Dietary restriction of sodium has been suggested to prevent fluid overload and adverse outcomes for patients with heart failure. We designed the Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) to test whether or not a reduction in dietary sodium reduces the incidence of future clinical events.Methods SODIUM-HF is an international, open-label, randomised, controlled trial that enrolled patients at 26 sites in six countries (Australia, Canada, Chile, Colombia, Mexico, and New Zealand). Eligible patients were aged 18 years or older, with chronic heart failure (New York Heart Association [NYHA] functional class 2-3), and receiving optimally tolerated guideline-directed medical treatment. Patients were randomly assigned (1:1), using a standard number generator and varying block sizes of two, four, or six, stratified by site, to either usual care according to local guidelines or a low sodium diet of less than 100 mmol (ie,