Key result
RISE-HF evaluates oral sucrosomial iron for exercise capacity and quality of life in HF.
Why the study?
Conventional oral iron has not improved clinical outcomes in HF and iron deficiency due to poor absorption, whereas sucrosomial iron partially bypasses hepcidin-controlled absorption.
Does oral sucrosomial iron improve exercise capacity and quality of life in patients with heart failure and iron deficiency?
RCT (n=60)
Double-blind, placebo-controlled
1:1 block randomization, stratified by hemoglobin strata
No
Does oral sucrosomial iron improve exercise capacity and quality of life in patients with heart failure and iron deficiency?
The RISE-HF trial will determine whether oral sucrosomial iron can safely improve exercise capacity, quality of life, and iron status in patients with heart failure and iron deficiency.
Sucrosomial iron remains unproven in HF with iron deficiency; RISE-HF will deliver the first RCT data on exercise capacity and quality of life.
Aims Compared with intravenous iron, oral iron is less expensive, avoids healthcare complexities, and reduces the risk of iron overload. However, conventional oral formulations have not improved clinical outcomes in heart failure (HF) and iron deficiency (ID), largely due to poor absorption. Sucrosomial iron (SI) partially bypasses hepcidin-controlled absorption and showed favorable effects in a small case-control study, warranting further evaluation in a randomized trial. Methods The Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure (RISE-HF; NCT06270498 ) is a randomized, placebo-controlled, double-blind study enrolling 60 patients with HF with left ventricular ejection fraction <50%, ID (transferrin saturation (TSAT) < 20%), ferritin <400 μg/L and hemoglobin (Hb) 10–16 g/dL. Participants are randomized 1:1 to receive SI (Sideral Forte®: sucrosomial iron 30 mg + 70 mg vitamin C) or placebo for 24 weeks, with daily dose tailored to Hb (2 capsules for Hb 10–13.9 g/dL; 1 capsule for Hb 14–16 g/dL). Co-primary endpoints are changes from baseline to week 12 in exercise capacity, assessed by the 6-min walk test (6MWT) distance, and in quality of life, assessed by the Kansas City Cardiomyopathy Questionnaire-12. Secondary endpoints include changes in individual co-primary endpoints at week 24, effects on iron status and oxidative stress biomarkers, N-terminal pro type-B natriuretic peptide and echocardiographic indices of cardiac function, and gastrointestinal tolerability. Conclusions RISE-HF will determine whether SI can safely improve exercise capacity, quality of life, and iron status in patients with HF and TSAT-defined ID, justifying a larger multicenter trial.
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Masini et al. (2026) conducted an RCT in Heart failure with LVEF <50% and iron deficiency (n=60). Sucrosomial iron vs. Placebo was evaluated on Changes from baseline to week 12 in 6-min walk test (6MWT) distance and Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall score. The RISE-HF trial is an ongoing randomized study designed to evaluate whether sucrosomial iron improves exercise capacity and quality of life in patients with heart failure and iron deficiency.
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