Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomized, controlled trial

context

Dietary sodium restriction has been suggested to prevent fluid overload and adverse effects in patients with heart failure. We designed the 100 mmol Dietary Intervention Study in Heart Failure (SODIUM-HF) to test whether or not reducing dietary sodium reduces the incidence of future clinical events.

Methods

SODIUM-HF is an international, open-label, randomized and controlled trial which recruited patients at 26 sites in six countries (Australia, Canada, Chile, Colombia, Mexico and New Zealand). Eligible patients were 18 years of age or older and had chronic heart failure (New York Heart Association [NYHA] functional class 2-3) and receiving medical treatment in line with the guidelines and tolerated optimally. Patients were randomly assigned (1:1), using a standard number generator and variable sized blocks of two, four or six, stratified by site, either to usual care according to local guidelines, or on a low sodium diet of less than 100 mmol (i.e. ClinicalTrials.gov, NCT02012179, and is closed to regularization.

Results

Between March 24, 2014 and December 9, 2020, 806 patients were randomly assigned to a low sodium diet (n=397) or usual care (n=409). The median age was 67 years (IQR 58–74) and 268 (33%) were female and 538 (66%) were male. Between baseline and 12 months, median sodium intake decreased from 2286 mg/day (IQR 1653–3005) to 1658 mg/day (1301–2189) in the low sodium group and 2119 mg/day (1673–2804) to 2073 mg/day (1541–2900) in the usual care group. At 12 months, primary endpoint events had occurred in 60 (15%) of 397 patients in the low sodium diet group and 70 (17%) of 409 patients in the usual care group (relative risk [HR] 0 89 [95% CI 0·63–1·26]; p=0 53). All-cause death occurred in 22 (6%) patients in the low sodium group and 17 (4%) in the usual care group (HR 1 38 [0·73–2·60]; p=0 32), hospitalization for cardiovascular reasons 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 CVD-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 study treatment were reported in either group.

Interpretation

In ambulatory patients with heart failure, dietary intervention to reduce sodium intake did not reduce clinical events.

Funding

Canadian Institutes of Health Research and University Hospital Foundation, Edmonton, Alberta, Canada, and Health Research Council of New Zealand.

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