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

Abstract

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.

Iron Deficiency in CKD Without Concomitant Anemia

“…59 In a recently published study, however, oral sucrosomial iron was associated with improved exercise capacity and quality of life in patients with HFrEF and ID; however, only 25 patients were included in this trial, which was open-label and not randomized. 60 The current body of evidence, as described above, supports the use of i.v. iron to treat ID (serum ferritin <100 ng/ml, or ferritin between 100 and 300 ng/ml and TSAT <20%) in HF with HFrEF regardless of the presence or absence of anemia, in order to improve functional status and quality of life.…”

April 2021 at a glance: focus on systolic function, quality of life and treatment in heart failure

“…Iron deficiency is a major therapeutic target in HF 9,14,22 . In a non‐randomized, open‐label, prospective pilot study, oral sucrosomial iron improved exercise capacity and QoL in patients with HFrEF and Iron deficiency, with significant improvement in 6‐min walk distance and KCCQ at 3 and 6 months (all adjusted P ‐values <0.01) 23 …”

“…9,14,22 In a nonrandomized, open-label, prospective pilot study, oral sucrosomial iron improved exercise capacity and QoL in patients with HFrEF and Iron deficiency, with significant improvement in 6-min walk distance and KCCQ at 3 and 6 months (all adjusted P-values <0.01). 23 stromal cells (MSCs) in patients with ischaemic HF. 24 The Phase II CONCERT-HF trial demonstrated that the combination of MSCs and c-kit positive cardiac cells was associated with further improvement in clinical outcome and QoL.…”

Oral sucrosomial iron in heart failure with a reduced ejection fraction

“…In this issue of the Journal, Karavidas et al 14 . report, for the first time, the results of a non‐randomized, single‐centre, uncontrolled, open‐label study of the effects of SI in HFrEF.…”

“…In an open-label randomized trial in renal patients, SI was well tolerated and as effective as IV ferrous gluconate in correcting anaemia. 13 In this issue of the Journal, Karavidas et al 14 report, for the first time, the results of a non-randomized, single-centre, uncontrolled, open-label study of the effects of SI in HFrEF. They enrolled 50 patients with symptomatic chronic HFrEF, a left ventricular ejection fraction <40%, and ID as defined by the FERRIC-HF criteria (ferritin <100 μg/L or ferritin 100-300 μg/L with transferrin saturation <20%).…”