SODIUM-HF trial sheds some light on the need of dietary salt restriction in heart failure patients

Heart failure is associated with neurohormonal activation and abnormalities in autonomic control that lead to sodium and water retention; thus, dietary restriction of sodium has been historically endorsed as a mechanism to prevent fluid overload and subsequent clinical outcomes; however, clinical trials so far have shown mixed results. As a result, many heart failure guidelines now do not make any recommendations on dietary sodium. On April, 2, the results of a new randomized trial on sodium restriction in heart failure were presented at the American College of Cardiology (ACC) 2022 Scientific Session, and they were also simultaneously published online in The Lancet.

SODIUM-HF was an international, open-label, randomised, controlled trial that enrolled patients at 26 sites in six countries. 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. A total of 806 patients were randomly assigned (1:1) to either usual care according to local guidelines (n=409) or a low sodium diet of less than 100 mmol (ie, <1500 mg/day) (n=397). The primary outcome was the composite of cardiovascular-related admission to hospital, cardiovascular-related emergency department visit, or all-cause death within 12 months.

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). The absence of treatment effect for the primary outcome was consistent across most prespecified subgroups, including those with higher vs lower baseline sodium intake.

Despite disappointing clinical events data, quality-of-life measures on the Kansas City Cardiomyopathy Questionnaire (KCCQ) suggested a benefit in the low-sodium group, with mean between-group differences in the change from baseline to 12 months of 3.38 points in the overall summary score, 3.29 points in the clinical summary score, and 3.77 points in the physical limitation score (all differences were statistically significant). No safety events related to the study treatment were reported in either group.


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