加拿大阿尔伯塔大学Justin A Ezekowitz团队研究了心力衰竭患者膳食钠水平降至100 mmol以下对临床结局的影响。相关论文于2022年4月5日发表在《柳叶刀》杂志上。
建议饮食中限制钠的摄入已被建议来预防心力衰竭患者的体液过多和不良预后。研究组设计了一项100 mmol心衰饮食干预研究，以测试饮食中钠的减少是否会降低未来临床事件的发生率。
研究组进行了一项国际性、开放标签、随机、对照试验，在六个国家（澳大利亚、加拿大、智利、哥伦比亚、墨西哥和新西兰）的26个机构招募患者。符合条件的患者年龄为18岁及以上，患有慢性心力衰竭（纽约心脏协会[NYHA]功能分级2-3级），并接受指南指导的最佳耐受性药物治疗。
将患者按1：1随机分配，根据当地指南接受常规护理或低于100 mmol（即<1500 mg/天）的低钠饮食。主要结局是意向治疗（ITT）人群（即所有随机分配的患者）在12个月内心血管相关入院、心血管相关急诊就诊或全因死亡的综合结局。对ITT人群进行安全性评估。
2014年3月24日至2020年12月9日，806名患者被随机分配到低钠饮食组（397名）或常规护理组（409名）。中位年龄为67岁，268名（33%）为女性，538名（66%）为男性。
在基线检查和12个月期间，低钠饮食组的中位钠摄入量从2286 mg/天降至1658 mg/天，而常规护理组的中位钠摄入量从2119 mg/天降至2073 mg/天。到12个月时，低钠饮食组中有60名（15%）发生了主要结局事件，常规护理组中有70名（17%），组间差异不显著。
低钠饮食组有22名（6%）患者、常规护理组有17名（4%）发生全因死亡；低钠饮食组有40名（10%）患者、常规护理组有51名（12%）发生心血管相关住院；低钠饮食组有17名（4%）患者、常规护理组有15名（4%）出现心血管相关急诊就诊。两组均未报告与研究治疗相关的安全事件。
研究结果表明，对于患有心力衰竭的非卧床患者，减少钠摄入量的饮食干预并没有减少临床事件。
附：英文原文
Title: Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial
Author: Justin A Ezekowitz, Eloisa Colin-Ramirez, Heather Ross, Jorge Escobedo, Peter Macdonald, Richard Troughton, Clara Saldarriaga, Wendimagegn Alemayehu, Finlay A McAlister, JoAnne Arcand, John Atherton, Robert Doughty, Milan Gupta, Jonathan Howlett, Shahin Jaffer, Andrea Lavoie, Mayanna Lund, Thomas Marwick, Robert McKelvie, Gordon Moe, A Shekhar Pandey, Liane Porepa, Miroslaw Rajda, Haunnah Rheault, Jitendra Singh, Mustafa Toma, Sean Virani, Shelley Zieroth, Justin Ezekowitz, Eloisa Colin-Ramirez, Heather Ross, Jorge Escobedo, Peter Macdonald, Richard Troughton, Clara Saldarriaga, Wendimagegn Alemayehu, Finlay McAlister, JoAnne Arcand, John Atherton, Robert Doughty, Milan Gupta, Jonathan Howlett, Shahin Jaffer, Andrea Lavoie, Mayanna Lund, Thomas Marwick, Robert McKelvie, Gordon Moe, A. Shekhar Pandey, Liane Porepa, Miroslaw Rajda, Haunnah Rheault, Jitendra Singh, Mustafa Toma, Sean Virani, Shelley Zieroth
Issue&Volume: 2022-04-05
Abstract:
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, <1500 mg/day). The primary outcome was the composite of cardiovascular-related admission to hospital, cardiovascular-related emergency department visit, or all-cause death within 12 months in the intention-to-treat (ITT) population (ie, all randomly assigned patients). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT02012179, and is closed to accrual.
Findings
Between March 24, 2014, and Dec 9, 2020, 806 patients were randomly assigned to a low sodium diet (n=397) or usual care (n=409). Median age was 67 years (IQR 58–74) and 268 (33%) were women and 538 (66%) were men. Between baseline and 12 months, the median sodium intake decreased from 2286 mg/day (IQR 1653–3005) to 1658 mg/day (1301–2189) in the low sodium group and from 2119 mg/day (1673–2804) to 2073 mg/day (1541–2900) in the usual care group. By 12 months, events comprising the primary outcome had occurred in 60 (15%) of 397 patients in the low sodium diet group and 70 (17%) of 409 in the usual care group (hazard ratio [HR] 0·89 [95% CI 0·63–1·26]; p=0·53). All-cause death occurred in 22 (6%) patients in the low sodium diet group and 17 (4%) in the usual care group (HR 1·38 [0·73–2·60]; p=0·32), cardiovascular-related hospitalisation occurred in 40 (10%) patients in the low sodium diet group and 51 (12%) patients in the usual care group (HR 0·82 [0·54–1·24]; p=0·36), and cardiovascular-related emergency department visits occurred in 17 (4%) patients in the low sodium diet group and 15 (4%) patients in the usual care group (HR 1·21 [0·60–2·41]; p=0·60). No safety events related to the study treatment were reported in either group.
Interpretation
In ambulatory patients with heart failure, a dietary intervention to reduce sodium intake did not reduce clinical events.
DOI: 10.1016/S0140-6736(22)00369-5
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00369-5/fulltext
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
官方网址：http://www.thelancet.com/
投稿链接：http://ees.elsevier.com/thelancet
本期文章：《柳叶刀》：Online/在线发表
