心力衰竭患者钠摄入低于 100mmol 膳食干预研究（SODIUM-HF）的原理和设计。
Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
机构信息
National Council of Science and Technology (CONACYT), and National Institute of Cardiology 'Ignacio Chavez', Mexico City, Mexico; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
出版信息
Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.
BACKGROUND
Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF.
METHODS
The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients.
CONCLUSIONS
The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
背景
尽管进行了医学和器械治疗，心力衰竭（HF）患者仍存在较高的未来事件风险。根据有限的证据，常建议减少饮食中的钠摄入量。但是，减少饮食中的钠摄入量是否能降低 HF 相关的发病率或死亡率尚不清楚。
方法
SODIUM 研究是一项实用、随机、开放性试验，评估了将饮食中的钠摄入量减少至<1500mg/天的咨询与常规护理相比，对慢性 HF 患者的疗效。干预措施由现场的经过培训的人员提供，并使用 3 天的食物记录来指导咨询。主要结局是在 12 个月时测量的首次心血管事件或死亡的意向治疗分析。次要终点包括生活质量（使用堪萨斯城心肌病问卷）、纽约心脏协会（NYHA）心功能分级的变化和 6 分钟步行试验的变化。首例患者于 2014 年 3 月入组，随后，6 个国家的 27 个站点开始入组患者。
结论
SODIUM-HF 试验将对 HF 患者减少饮食中的钠摄入量的效果进行强有力的评估。预计结果将于 2020 年公布。
Zotero 插件