Study of Dietary Intervention Under 100 mmol in Heart Failure - SODIUM-HF

Contribution To Literature:

The SODIUM-HF trial failed to show that a low-sodium diet prevented adverse cardiovascular events.

Description:

The goal of the trial was to evaluate a low-sodium diet compared with usual care among ambulatory patients with heart failure.

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Stratified

Patients with New York Heart Association (NYHA) class II-III heart failure symptoms on optimal medical therapy were randomized to a low-sodium diet (<1500 mg daily) (n = 397) versus usual care (n = 409).

  • Total number of enrollees: 806
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 32%
  • Percentage with diabetes: 33%

Inclusion criteria:

  • Patients ≥18 years of age with heart failure (preserved or reduced left ventricular systolic function)
  • NYHA class II-III symptoms
  • End-stage renal disease on hemodialysis
  • Uncontrolled thyroid or end-stage liver failure
  • Cardiac device or revascularization in the previous month or planned in the next 3 months
  • Hospitalization for cardiovascular cause in the last month
  • Uncontrolled atrial fibrillation
  • Active malignancy with expected life span <2 years
  • Poor compliance with the study protocol
  • Enrollment in another study

Exclusion criteria:

  • Average daily sodium intake <1500 mg
  • Serum sodium <130 mmol/L

Other salient features/characteristics:

  • Mean ejection fraction: 36%
  • Atrial fibrillation: 39%
  • At 12 months, dietary sodium intake was 1658 mg in the low-sodium diet group vs. 2073 mg in the usual care group (p < 0.0001).

Principal Findings:

The trial was terminated early due to impact from the COVID-19 pandemic.

The primary outcome, all-cause mortality, or cardiovascular emergency department visit/hospitalization at 12 months, occurred in 15% of the low-sodium group vs. 17% of the usual care group (hazard ratio [HR] 0.89, p = 0.53).

Secondary outcomes:

  • All-cause mortality at 12 months: 6% of the low-sodium group vs. 4% of the usual care group (HR 1.38, p = 0.32)
  • The difference in the adjusted mean Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months was 3.38 points greater in the low-sodium group vs. usual care group (p = 0.011).
  • The difference in the adjusted mean 6-minute walk test at 12 months was 6.6 minutes greater in the low-sodium group vs. usual care group (p = 0.41).

Interpretation:

Among ambulatory patients with heart failure, a low-sodium diet was not associated with a reduction in adverse cardiovascular events. A low-sodium diet was associated with a modest improvement in quality of life; however, 6-minute walk test was not different between treatment groups. Unfortunately, the trial was terminated early, limiting interpretation of the findings.

References:

Ezekowitz JA, Colin-Ramirez E, Ross H, et al., on behalf of the SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomized, controlled trial. Lancet 2022;Apr 2:[Epub ahead of print].

Presented by Dr. Justin A. Ezekowitz at the American College of Cardiology Annual Scientific Session (ACC 2022), Washington, DC, April 2, 2022.

Keywords: ACC22, ACC Annual Scientific Session, Atrial Fibrillation, Cardiomyopathies, COVID-19, Defibrillators, Implantable, Diet, Sodium-Restricted, Emergency Service, Hospital, Heart Failure, Kidney Failure, Chronic, Liver Failure, Neoplasms, Quality of Life, Renal Dialysis, Secondary Prevention, Sodium, Sodium, Dietary, Stroke Volume


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