SODIUM-HF
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
67.0% male
N = 806
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 < 1,500 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 < 1,500 mg/day).
N=409 usual sodium intake (usual care according to local guidelines).
Primary outcome
A composite of admission to hospital for cardiovascular causes, emergency department visit for cardiovascular causes, or all-cause mortality at 12 months
15%
17%
17.0 %
12.8 %
8.5 %
4.3 %
0.0 %
Reduced sodium
intake
Usual sodium
intake
No significant
difference ↔
No significant difference in a composite of admission to hospital for cardiovascular causes, emergency department visit for cardiovascular causes, or all-cause mortality at 12 months (15% vs. 17%; HR 0.89, 95% CI 0.63 to 1.26).
Secondary outcomes
No significant difference in all-cause mortality (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 all-cause mortality 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.
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