SODIUM-HF: Does Strictly Limiting Sodium Intake Reduce Cardiac Events, Improve QOL in HF Patients?

While nutrition counseling and strictly limiting sodium intake for one year in patients with heart failure (HF) resulted in modest improvements in quality of life (QOL) and a slowing in the progression of the disease, dietary intervention did not significantly reduce major adverse events or hospitalizations, based on results from the SODIUM-HF trial presented April 2 during ACC.22 and simultaneously published in The Lancet.

For the study, researchers enrolled 841 patients treated for HF at 26 medical centers in six countries (Canada, Australia, New Zealand, Mexico, Colombia and Chile). Study participants were randomly assigned to receive usual care (general advice to reduce sodium intake) or a low-sodium diet (<1500 mg daily (<65 mmol/daily). Those assigned to the low-sodium diet received nutritional counseling tailored to their dietary patterns, including menus individualized to the region or country. Researchers calculated each participant's average daily sodium intake based on frequent three-day food questionnaires throughout the study.

At the end of 12 months, the study, which was stopped early due to the COVID-19 pandemic, did not reach it primary endpoint of a composite outcome of all-cause mortality, cardiovascular hospitalizations or cardiovascular-related emergency department visits. While the total number of these events was numerically lower in the low-sodium diet group, researchers said the difference was not statistically significant, even after adjusting for health-related and demographic differences (HR 0.80; 95% CI 0.64-1.26; p=0.53). However, secondary analyses did suggest improvements in QOL as measured by the Kansas City Cardiomyopathy Questionnaire and in New York Heart Association (NYHA) class in the low-sodium group, compared with those assigned to usual care. There was also no statistical difference between the two groups in terms of the 6-minute walk test. Although researchers did note a trend toward longer walking times among those who received the intervention.

"While the intervention didn't reduce clinical events, we found the low-sodium group had modest improvements in QOL and NYHA HF class, which we think will be quite important and valued by patients and clinicians alike," said Justin A. Ezekowitz, MBBCh, FACC, the study's lead author. "We need to explore further whether there might be a way to individualize recommendations from our trial to see if the QOL benefits might make it worth it for certain patients [to reduce sodium intake]."

The researchers plan to continue the study and assess outcomes at 24 months. Current dietary guidelines in the U.S., including the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease, recommend limiting sodium but do not specify a target daily amount. Guidelines in the U.S. and Europe previously recommended limiting dietary sodium intake to 2,400 mg per day.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Annual Scientific Session, ACC22, Heart Failure, Sodium, Sodium, Dietary

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