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Surprise outcome for SODIUM-HF

Presented By
Prof. Justin Ezekowitz, University of Alberta, Canada
ACC 2022
Phase 3, SODIUM-HF
Heart failure (HF) patients are often suggested to reduce dietary sodium to prevent fluid overload. However, the randomised controlled SODIUM-HF trial showed that a reduction in sodium intake did not reduce clinical events overall. Nevertheless, some individual patients did receive benefits, including quality-of-life (QoL) improvements and ameliorated HF progression over time.

Prof. Justin Ezekowitz (University of Alberta, Canada) presented the results of the SODIUM-HF (NCT02012179) trial, which was simultaneously published in The Lancet [1,2]. Participants were randomly assigned (1:1) to either usual care according to local guidelines (n=409) or a low-sodium diet <1,500 mg/day for 1 year (n=397). The mean age of the participants was 66 years, 32% were women and 35% had diabetes. The primary endpoint was the composite of cardiovascular-related admission to hospital, cardiovascular-related emergency department visit, or all-cause death within 12 months. Enrollment was stopped early after only about half of the planned patient population had been recruited due to the COVID-19 pandemic.

At 12 months, primary outcome events had occurred in 15% in the low-sodium group, as compared with 17% in the control group (HR 0.89; 95% CI 0.63–1.26; P=0.53). Likewise, death from any cause was not different between the groups (6% of participants in the low-sodium group vs 4% in the usual care group; HR 1.38; 95% CI 0.73–2.60; P=0.32). Also, no significant difference were seen in cardiovascular-related hospitalisation (10% low-sodium group vs 12% control group; HR 0.82; 95% CI 0.54–1.24; P=0.36) and cardiovascular-related emergency department visits (4% in both groups; HR 1.21; 95% CI 0.60–2.41; P=0.60). Subgroup analyses did not reveal any meaningful differences. There were no safety events in either group. However, as a QoL measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ) revealed a difference of 3.38 points from baseline to 12 months in the overall score, 3.29 points in the clinical summary score, and 3.77 points in the physical limitation score, indicating an overall QoL improvement for the low-sodium group.

In summary, a dietary intervention to reduce sodium intake did not reduce HF-related clinical events in this trial. Prof. Ezekowitz concluded that while the study was underpowered given a low number of events to detect a meaningful difference statistically, observed differences in QoL warrant further investigation.

    1. Ezekowitz JA, et al. SODIUM-HF: Study Of Dietary Intervention Under 100 Mmol In Heart Failure. Abstract 402–11, ACC 2022, 2–4 April, Washington DC, USA.

    2. Ezekowitz JA, et al. Lancet 2022;399(10333):1391–1400.


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