6/29/23, 11:44 PM SODIUM-HF Pathway Feedback Search Clinical Topics Home Studies SODIUM HF SODIUM HF Disease Heart failure Trial question What is the role of dietary intervention to reduce sodium intake in patients with HF? Study design Multi-center Open label RCT Population Characteristics of study participants 33.0% female N = 806 67.0% male 806 patients (268 female, 538 male) Inclusion criteria: adult patients with chronic HF receiving optimally tolerated medical treatment Key exclusion criteria: average dietary intake of sodium < 1500 mg/day; serum sodium < 130 mmol/L; renal failure; hepatic failure; uncontrolled thyroid disorder; uncontrolled AF; hospitalization due to cardiovascular causes in the previous month Interventions N=397 reduced sodium intake (sodium intake < 1500 mg/day) N=409 usual sodium intake (usual care according to local guidelines) Primary outcome https://web.pathway.md/studies/recNj64shxbvZamVm 1/2 6/29/23, 11:44 PM SODIUM-HF Pathway A composite of admission to hospital for cardiovascular causes, emergency department visit for cardiovascular causes, or death from all causes at 12 months 17.0 % 17 15 12.8 % 8.5 % 4.3 % No significant difference 0.0 % Reduced sodium intake Usual sodium intake No significant difference in a composite of admission to hospital for cardiovascular causes, emergency department visit for cardiovascular causes, or death from all causes at 12 months (15% vs. 17%; HR 0.89, 95% CI 0.63 to 1.26) Secondary outcomes No significant difference in death from all causes (6% vs. 4%; HR 1.38, 95% CI 0.73 to 2.6) No significant difference in hospitalization for cardiovascular causes (10% vs. 12%; HR 0.82, 95% CI 0.54 to 1.24) No significant difference in cardiovascular-related emergency department visits (4% vs. 4%; HR 1.21, 95% CI 0.6 to 2.41) Conclusion In adult patients with chronic HF receiving optimally tolerated medical treatment, reduced sodium intake was not superior to usual sodium intake with respect to a composite of admission to hospital for cardiovascular causes, emergency department visit for cardiovascular causes, or death from all causes at 12 months. Reference Justin A Ezekowitz, Eloisa Colin-Ramirez, Heather Ross 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 Apr 9;399(10333):1391-1400. Open reference URL https://web.pathway.md/studies/recNj64shxbvZamVm 2/2