Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure — RISE-HF  

Chronic Heart Failure Clinical Trial

Official title: Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure: a Randomized, Placebo-controlled Trial (RISE-HF)

Status Recruiting

Clinical Trial Summary

The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).

The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.

One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.

Clinical Trial Description

Based on clinical trials, treatment with intravenous iron improves symptoms, exercise capacity, and may reduce HF hospitalizations in patients with HF and ID. On the contrary, treatment of ID with oral iron has no effect on exercise capacity. High hepcidin levels prevent oral intestinal absorption and blunt the response to oral iron administration. Sucrosomial iron (SI) consists of a nucleus of ferric pyrophosphate with an envelope of sucrose ester of fatty acids, which promotes intestinal absorption through paracellular and lymphatic routes, independent of hepcidin. In contrast with intravenous iron infusion, administration of oral iron may not promote oxidative stress, since the intestinal iron absorption prevent the formation of labile, non-transferrin bound, plasma iron.

The study will investigate the effect of oral SI supplementation on exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo in patients with HF, a left ventricular ejection fraction (LVEF) <50%. Iron deficiency was defined as transferrin saturation (TSAT) <20%. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Heart Failure
• Heart Failure
• Iron-deficiency
• Left Ventricular Systolic Dysfunction
• Ventricular Dysfunction, Left

• NCT number: NCT06270498
• Study type: Interventional
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Gabriele Masini, MD PhD
• Phone: 0039 050996712
• Email: gabriele.masini@unipi.it
• Status: Recruiting
• Phase: Phase 4
• Start date: March 14, 2024
• Completion date: June 14, 2025