Oral sucrosomial iron improves exercise capacity and quality of life in heart failure with reduced ejection fraction and iron deficiency: a non-randomized, open-label, proof-of-concept study.

AIMS: Oral sucrosomial iron (SI) combines enhanced bioavailability and tolerance compared to conventional oral iron along with similar efficacy compared to intravenous iron in several conditions associated with iron deficiency (ID). METHODS AND RESULTS: In this non-randomized, open-label study, we sought to evaluate prospectively the effects of SI on clinical parameters, exercise capacity and quality of life in 25 patients with heart failure (HF) with reduced ejection fraction (HFrEF) and ID, treated with SI 28 mg daily for 3 months, in comparison to 25 matched HFrEF controls. All patients were on optimal stable HF therapy. Patients were followed for 6 months for death or worsening HF episodes. There were no differences in baseline characteristics between groups. At 3 months, SI was associated with a significant increase in haemoglobin, serum iron and serum ferritin levels (all P ≤ 0.001) along with a significant improvement in 6-min walked distance and Kansas City Cardiomyopathy Questionnaire (all P < 0.01), even after adjustment for baseline parameters; these differences persisted at 6 months. Over the study period, there were no deaths, while 10 patients (20%) in total (four in the SI group and six in the control group), experienced worsening HF (odds ratio 0.51, 95% confidence interval 0.41-6.79, P = 0.482). Drug-associated diarrhoea was reported by one patient in the SI group and led to drug discontinuation; no other adverse events were reported. CONCLUSIONS: In this proof-of-concept study, SI was well tolerated and improved exercise capacity and quality of life in HFrEF patients with ID. Randomized studies are required to further investigate the effects of this therapy.

Safety and efficacy of salt substitution with a low sodium-potassium enriched dietary salt in patients with heart failure with reduced ejection fraction: A pilot study.

BACKGROUND AND AIMS: Increased sodium intake is associated with increased risk of decompensation in patients with heart failure. This non-randomized, open-label, controlled study aimed to examine the feasibility, preliminary safety and efficacy of a low sodium-potassium enriched salt substitute compared to regular table salt in patients with heart failure with reduced ejection fraction (HFREF). METHODS: Fifty patients (68% male, NYHA I/II/III 6%/68%/26%, mean age 70 ± 9 years, LVEF 31 ± 5%, median BNP 112 pg/ml) were included. Of these, 30 patients received the salt substitute (maximum consumption of 2 g daily), who were prospectively compared to a control group of 20 age/sex/NYHA class-matched HFREF patients who consumed regular salt (maximum consumption of 2 g daily). Consumption of regular salt was prohibited in the salt substitution group. All patients were followed for 12 weeks. RESULTS: Patient groups did not differ by sex, age, LVEF, NYHA class, 6MWD, and BNP at baseline. In primary safety analysis, no significant differences were detected between groups regarding SBP (p = 0.052), DBP (p = 0.159), HR (p = 0.246), serum potassium (p = 0.579), serum sodium (p = 0.125), and eGFR (p = 0.710) throughout the 12 weeks. Secondary efficacy analysis revealed a statistically significant difference in 6MWD at 12 weeks between the salt substitute and regular salt groups after adjustment for baseline 6MWD (mean difference±SEM, 4.7 ± 2.1 m, F = 4.92, p = 0.031). CONCLUSIONS: In this pilot study, a low sodium-potassium enriched salt substitute was found to be safe compared to regular salt in HFREF patients, while it resulted in a small albeit significant improvement in exercise capacity, possibly justifying further investigation with randomized clinical studies.