Rationale and design of the RISE-HF trial: sucrosomial iron in heart failure

Area of Science:

• Cardiology
• Nutritional Science
• Pharmacology

Background:

• Oral iron is preferred over intravenous iron for cost and safety, but conventional formulations show poor absorption and limited clinical benefit in heart failure (HF) patients with iron deficiency (ID).
• Sucrosomial iron (SI) is a novel oral formulation designed to bypass hepcidin-controlled absorption, potentially improving iron delivery and clinical outcomes.

Purpose of the Study:

• To evaluate the efficacy and safety of sucrosomial iron (SI) in improving exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).

Main Methods:

• The RISE-HF study is a randomized, placebo-controlled, double-blind trial involving 60 patients with HF (left ventricular ejection fraction <50%) and ID (TSAT <20%).
• Participants received either SI (30 mg iron + 70 mg vitamin C) or placebo for 24 weeks, with co-primary endpoints being changes in 6-minute walk test distance and Kansas City Cardiomyopathy Questionnaire-12 score at week 12.

Main Results:

• The study is ongoing, and primary results are not yet available.
• Secondary endpoints include iron status, oxidative stress biomarkers, N-terminal pro-B-type natriuretic peptide, cardiac function, and gastrointestinal tolerability.

Conclusions:

• RISE-HF aims to determine if SI can safely enhance exercise capacity, quality of life, and iron status in HF patients with ID.
• Positive findings could support larger multicenter trials for SI in this population.