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Sex differences in the metabolic syndrome: implications for cardiovascular health in women. Clin Chem 2014; 60: 44–52. Sodium restriction in heart failure should be taken with a pinch of salt The time-worn, standard injunction against low-salt consumption in heart failure is not borne out by the evidence, writes MedicalBrief. The SODIUM-HF trial, conducted at 26 sites in six countries over six years, concludes that dietary intervention to reduce sodium intake did not reduce clinical events. Therapy for heart failure has come a long way in a short time, writes Dr John Mandrola in Medscape. Yet clinicians place substantial burden on patients with chronic heart failure, asking them to take numerous medicines, make frequent appointments, exercise and eat well. Strict sodium restriction is one of those burdens. He writes: at the American College of Cardiology (ACC) 2022 Scientific Session (2 April), Justin Ezekowitz, from the University of Alberta, Canada, presented results of the SODIUM-HF trial, which put this common recommendation to the test of randomisation. The Lancet simultaneously published the study. Before SODIUM-HF, there was little to no supportive evidence for strict sodium restriction. A systematic review of nine studies found no consistent benefit of low-sodium regimens. SODIUM-HF is a pragmatic randomised, controlled trial that tested general advice on dietary sodium against a low-sodium diet of 1 500 mg daily. Unlike drug trials, which can strictly control active and treatment arms in a relatively optimal setting, pragmatic trials test interventions in the real world. This difference influences how we interpret and apply the trial results. Patients in SODIUM-HF had class II–III New York Heart Association heart failure and were recruited mostly from primary care settings. They were typical of out-patients with heart failure: average age 66 years, average left ventricular ejection fraction of 36%, good medical therapy. The study was carried out in 26 sites in six countries over six years. Food and menus were individualised to local region and country. About 400 patients were in each arm. The primary endpoint was a composite of all-cause death and hospitalisation or emergency department visit for cardiovascular (CV) reasons. The average sodium intake, as measured by three-day food records, was approximately 2 000 mg/day in the control group and about 1 600 mg/day in the low-sodium arm. A primary outcome occurred in 15% of the low-sodium arm versus 17% of the control arm, which did not meet statistical significance (hazard ratio 0.89; 95% CI: 0.69–1.26; p = 0.53). Death, CV hospitalisations and CV emergency department visits did not differ significantly between groups. Patients in the low-sodium arm scored significantly better on the Kansas City Cardiomyopathy Questionnaire, which measures a person’s perception of their health. A caveat here is that the trial was open-label, so a placebo effect is possible. The authors concluded with just one spin-free sentence: ‘In ambulatory patients with heart failure, a dietary intervention to reduce sodium intake did not reduce clinical events.’ Comments Since the results and conclusions were so clear, let’s discuss the trial’s limitations, which influence how we translate this finding to the care of patients. At ACC and online, SODIUM-HF endured some pushback. It stirred a defensive urge in me. continued on page 34
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