WASHINGTON — A dietary intervention reduced sodium intake, but did not reduce clinical events, for people with heart failure (HF), according to the SODIUM-HF trial.

Between patients randomized to a low-sodium diet or usual care for 12 months, there was no statistically significant difference in the combined outcome of cardiovascular-related admissions to hospital, cardiovascular-related emergency department visits, and all-cause death in the trial (15% vs 17%, HR 0.89, 95% CI 0.63-1.26), reported Justin Ezekowitz, MBBCh, of the University of Alberta in Edmonton, Canada.

However, sodium restriction was associated with moderate improvements in quality of life (QoL) and New York Heart Association (NYHA) functional class, according to the late-breaking trial presented at the American College of Cardiology (ACC) meeting. Results were simultaneously published in the Lancet.

Ezekowitz urged clinicians to continue recommending a low-sodium diet as a therapy to improve QoL as part of an overall health strategy for HF patients.

Notably, his group had estimated that approximately 1,000 patients would be needed for the trial. The 806-person trial had been stopped early due to a variety of reasons including futility, feasibility, and COVID-19.

ACC past president Mary Norine Walsh, MD, of St. Vincent Heart Center in Indianapolis, noted that the average sodium intake in the U.S. is 3,400 mg per day.

She stressed the importance of patient-centered outcomes, and how people can feel better anecdotally from sodium restriction. SODIUM-HF reassures patients that if they slip up with their salt intake one day, they may not end up in the hospital, she said during an ACC press conference.

The dietary intervention in the study targeted <1,500 mg sodium per day — approximately two-thirds of the 2,300 mg target listed in the Dietary Guidelines for Americans — and provided participants with meal plans and sample menus tailored to their energy requirements, energy distribution, and regional tastes. Behavioral counseling supported the intervention.

People randomized to the sodium intervention saw median daily sodium intake fall from 2,286 mg to 1,658 mg after 12 months. Peers in the control group had sodium intake reduced from 2,119 mg to just 2,073 mg.

ACC immediate past president Athena Poppas, MD, of Warren Alpert Medical School of Brown University in Providence, Rhode Island, questioned how meaningfully sodium reduction was reduced by the intervention in the study.

Sodium restriction has long been embraced by clinicians despite mixed results in clinical studies. “We’ve been chasing the holy grail of sodium reduction in HF for a very, very long time,” Poppas said following Ezekowitz’s presentation.

HF “is associated with neurohormonal activation and abnormalities in autonomic control that lead to sodium and water retention; thus, dietary restriction of sodium has been historically endorsed as a mechanism to prevent fluid overload and subsequent clinical outcomes; however, more recent data has questioned the validity of these recommendations,” Ezekowitz’s group noted.

For instance, geriatric HF patients did not have QoL improve significantly in the GOURMET-HF study of home-delivered sodium-restricted meals.

Conducted in six countries, the SODIUM-HF trial randomized people to the intervention or usual care, which included general advice to restrict dietary sodium provided during routine clinical practice.

Investigators recruited 806 people with chronic HF (NYHA class II-III) on maximally-tolerated, guideline-directed medical therapy. Participants had a median age of 67, and two-thirds were men. No data on race and ethnicity were available, although 22% of the participants in both groups were in Mexico, Chile, and Columbia.

Dietary sodium intake was assessed using 3-day food diaries at least at baseline, 6 months, and 12 months. These diaries suggested good adherence to the assigned diets, according to Ezekowitz.

He also reported that sodium restriction was not associated with any safety events.

Among the trial limitations were the lack of blinding among participants and the missing data on urinary biomarkers.

“Although 24 h [hour] urinary excretion is the gold standard dietary assessment method for sodium intake, food records are a valid dietary assessment technique in heart failure and the use of 24 h urine collections would have restricted trial feasibility and generated potentially misleading data for patients with heart failure on diuretics,” the investigators said.

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