Low-salt dietary intervention did not lower hospitalizations, death: SODIUM-HF
Click Here to Manage Email Alerts
WASHINGTON — A dietary intervention to reduce sodium intake did not reduce clinical events in ambulatory patients with HF, although researchers saw a modest benefit in quality of life measures, data from the SODIUM-HF trial show.
“Patients and their clinicians should have realistic expectations of the benefits of lowering dietary sodium,” Justin Ezekowitz, MB, BCH, MSc, FRCPC, FACC, FAHA, FESC, told Healio at the American College of Cardiology Scientific Session where the data were presented. “Guidelines should consider this information as the largest and longest trial of its type.”
For SODIUM-HF, Ezekowitz, who is professor of medicine in the division of cardiology, director of cardiovascular research and co-director of the Canadian VIGOUR Centre at the University of Alberta, and colleagues analyzed data from 806 adults in six countries with chronic HF (NYHA functional class II and III) and receiving optimally tolerated guideline-directed medical treatment from March 2014 to December 2020. The median age of participants was 67 years and 33% were women. Researchers randomly assigned participants to a low-sodium diet of less than 1,500 mg/day or usual care. The primary outcome was a composite of CV-related hospitalization, CV-related ED visits or all-cause death within 12 months.
The findings were simultaneously published in The Lancet.
From baseline to 12 months, median sodium intake decreased from 2,286 mg/day to 1,658 mg/day in the low-sodium group and from 2,119 mg/day to 2,073 mg/day in the usual care group.
By 12 months, primary outcome events occurred in 15% and 17% of participants in the low-sodium and usual care groups, respectively (HR = 0.89; 95% CI, 0.63-1.26; P = .53).
Other outcomes were similar between groups. All-cause death occurred in 6% and 4% of participants in the low-sodium and usual care groups, respectively (HR = 1.38; 95% CI, 0.73-2.6; P = .32), whereas CV-related hospitalization occurred in 10% and 12% of the low-sodium and usual care groups, respectively (HR = 0.82; 95% CI, 0.54-1.24; P = .36).
CV-related ED visits occurred in 4% of participants in both groups (HR = 1.21; 95% CI, 0.6-2.41; P = .6).
No safety events related to the study treatment were reported in either group.
“Clinical research should build off of this work and consider different populations, situations, and degree of sodium reduction and consider these for the topic of future clinical trials,” Ezekowitz told Healio.
Reference:
Perspective
Back to Top
Anu Lala, MD
The investigators of the SODIUM-HF trial enrolled over 800 patients who were randomly assigned to low sodium < 1,500 mg per day vs. unrestricted standard low sodium diets and found no difference in all-cause mortality, hospitalizations, ED visits, or 6-minute walk distance at 12 months but there was a modest approximately 3.5-point improvement in KCCQ quality of life score. Typically, a 5-point difference is considered clinically meaningful.
How are we to contextualize these findings? This was a large, multicenter, multinational study and the results challenge conventional wisdom and practice — so many of us HF clinicians ask our patients to refrain from salt under the assumption that excess sodium leads to excess congestion and thereby hospitalizations, but the relationship is likely more complex than just that. We are always humbled and reminded of why we do research. What you think is true may not be the case, hence the perpetual need for study and curiosity.
Perspective
Back to Top
Johanna Contreras, MD, MSc, FACC, FAHA, FASE
I congratulate the SODIUM-HF investigators in trying to assess the role of lower sodium in diet. It must be hard control for all the factors that are involved in patient’s diet and it will be hard to measure in clinical practice at many levels. The cohort includes a wide range of HF patients without NT-proBNP criteria, which could suggest that different degrees of sodium restriction are needed at different levels of illness. Even though the trial failed to meet its primary endpoint, it will be important to note that there were some improvements in markers like quality of life. Trying to restrict salt may have inspired patients to adopt other healthy behaviors, which would also be a good end result.
Perspective
Back to Top
Mary Norine Walsh, MD, MACC
First, the control group was given the usual guideline-directed care. Different centers may have different recommendations, but generally we tell patients to restrict sodium if they have volume overload. Not every single patient needs to. But, if they do, we have them generally restrict to less than 2,000 mg per day.
Will this [study] change our messaging? For me, I think my message to patients may be: ‘A new trial showed that if you lower to less than what we recommend usually, you might feel better.’ This is the first time we have evidence of what level of sodium leads to [patients] feeling better.
Collapse
Ezekowitz JA, et al. Joint American College of Cardiology/Journal of the American College of Cardiology Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
Read more about
Click Here to Manage Email Alerts