Reduction Of Dietary Sodium to Less Than 100 Mmol in Heart Failure (SODIUM-HF): An International, Open-Label, Randomised, Controlled Trial

Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Lancet. 2022 Apr 1:S0140-6736(22)00369-5. [CrossRef] [PubMed]

Dietary restriction of sodium has been a standard of care to prevent fluid overload and adverse outcomes for patients with heart failure. To test this hypothesis, the authors conducted the SODIUM-HF study which is an international, open-label, randomized, controlled trial that enrolled patients 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 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). 806 patients were enrolled and randomly assigned to a low sodium diet (n=397) or usual care (n=409). There was no statistical difference in mortality, hospitalizations, or emergency room visits (p>0.05 all comparisons). In ambulatory patients with heart failure, a dietary intervention to reduce sodium intake did not reduce clinical events.