Study of Dietary Intervention Under 100 mmoL in Heart Failure – The Sodium-HF trial

Presented at ACC.22 by Prof. Justin Ezekowitz, MD (Edmonton, AB, Canada)

Introduction and methods

Clinicians taking care of patients with heart disease and specially of patients with heart failure recommend that patients reduce dietary sodium intake to reduce the risk of volume overload. However, there is little evidence that supports this recommendation.

The SODIUM-HF study examined the effect of reduction of sodium intake in patients with heart failure. It was a randomized clinical trial that enrolled 841 patients with NYHA class II-III heart failure. Patients were randomized in a 1:1 ratio to a lower sodium diet (<1500 mg/day sodium intake) or usual care. Patients were followed for 12 months for the primary endpoint of a composite of all-cause mortality, CV hospitalizations or CV emergency department visits.

Results

• At 12 months, sodium intake was reduced by 415 mg/day in the intervention group. In the usual care arm, sodium intake was unchanged.
• There was no difference in the primary endpoint between the two groups (HR 0.89, 95%CI:0.63-1.26, P=0.53)
• Improvements in KCCQ summary score and KCCQ physical limitation score were greater in the low sodium group than in the usual care group (difference 3.38, 95%CI:0.79-5.96, P=0.011 and difference 3.37, 95%CI:0.67-6.87, P=0.017, respectively).

Conclusion

In ambulatory patients with HF who were enrolled in the SODIUM-HF trial, a dietary intervention of sodium intake reduction did not result in a reduction of clinical events compared to a usual care group. There was a modest benefit on quality of life, assessed by the KCCQ score. A change of 3 points was observed between the two group, which is clinically meaningful, said prof. Ezekowitz.

Also, there was modest benefit of clinical assessment of NYHA class with reduced sodium intake and no difference for the 6-minute walk test between the groups.

Discussion

The discussant, Mary Norine Walsh (Indianapolis, IN, USA) said that this trial has answered the question on sodium intake and hospitalization and death and whether people with sodium reduction feel better. It is important to remember that patient-centered outcomes are important too. She said: “We can safely tell our patients that if they slip up a bit, they may not end up in the hospital”.

– Our coverage of ACC.22 is based on the information provided during the congress –

Watch a video by prof. Ezekowitz on the SODIUM-HF trial