The RISE-HF trial is a randomized, double-blind study designed to evaluate whether sucrosomial iron improves exercise capacity and quality of life in 60 patients with heart failure; results are pending.
RCT (n=60)
Double-blind
1:1
No
Does sucrosomial iron improve exercise capacity and quality of life in patients with heart failure and iron deficiency?
The RISE-HF trial will evaluate whether oral sucrosomial iron can improve exercise capacity and quality of life in patients with heart failure and iron deficiency, potentially offering an alternative to intravenous iron.
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.
Masini et al. (Fri,) conducted a rct in Heart failure with iron deficiency (n=60). Sucrosomial iron vs. Placebo was evaluated on Changes from baseline to week 12 in exercise capacity (6MWT distance) and quality of life (KCCQ-12). The RISE-HF trial is a randomized, double-blind study designed to evaluate whether sucrosomial iron improves exercise capacity and quality of life in 60 patients with heart failure; results are pending.