Dietary sodium restriction has traditionally been advocated to prevent fluid overload and adverse outcomes for patients with heart failure (HF). The Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) was an international, open-label, randomized controlled trial designed to assess whether reduction in dietary sodium reduced the incidence of future clinical events. The primary outcome was a composite of cardiovascular-related admission to hospital, emergency department (ED) visit, or all-cause death.¹

In SODIUM-HF trial, 806 patients with chronic HF (New York Heart Association [NYHA]) class II-III receiving optimal guideline-directed medical therapy were randomized 1:1 to a low sodium diet of <1500 mg/day or usual care.¹ Over a 12 month period, all-cause death occurred in 6% of the low sodium and 4% of the usual care group (hazard ratio [HR] 1.38, p=0.32) while, cardiovascular-related hospitalization occurred in 10% of the low sodium and 12% of the usual care group (HR 0·82, p=0·36). Cardiovascular (CV) related ED visits also occurred in 4% of patients in the low sodium and usual care group (HR 1·21, p=0·60).¹

The SODIUM-HF trial showed that a low (<1500 mg/day) sodium diet did not reduce future CV clinical events in HF patients. The low sodium group showed a modest improvement in quality of life (improvement by one NYHA class and better Kansas City Cardiomyopathy Questionnaire [KCCQ] score), but there was no difference in 6-minute walk distance which could be attributed to examiner bias due to the open label nature of SODIUM-HF. Limitations include the premature trial termination due to futility and short-term follow-up (<12 months). The net difference in sodium between the groups was small (372 mg of sodium per day at 6 months (sodium ingestion of 2021 mg daily in the usual care group vs. 1649 mg daily in the low sodium diet group). This is important in patients in the United States with higher average daily sodium consumption approximately 3400 mg who were not included in the trial. Future trials should consider the efficacy of low sodium diet in the severity of HF (acute vs. chronic; ACC stage C or D) and the vulnerable post-discharge period. The congestion status, diuretic dosage, and the concomitant use of antagonists of the renin-angiotensin aldosterone system antagonists should also be considered. The results of SODIUM-HF highlight a paradigm shift away from strict dietary sodium restriction as a "one-size fits all" for HF patients.

References

1. Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet 2022;399:1391-1400.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Novel Agents, Acute Heart Failure, Diet

Keywords: ACC Annual Scientific Session, ACC22, Diet, Sodium-Restricted, Quality of Life, Aldosterone, Renin, Patient Discharge, Follow-Up Studies, Aftercare, Incidence, Medical Futility, Sodium, Dietary, Heart Failure, Emergency Service, Hospital, Cardiomyopathies, Angiotensins, Diuretics, Hospitals, Sodium

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