Oral Sucrosomial Iron Treatment to Improve Exercise Ability and Quality of Life in Heart Failure Patients with Iron Deficiency

What this Trial Is About

Researchers are evaluating the effects of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure HF who also have iron deficiency ID. This study aims to determine if oral sucrosomial iron improves exercise ability, measured by the six-minute walk test, and quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, compared to a placebo. Patients included have left ventricular ejection fraction LVEF less than 50% and iron deficiency defined by transferrin saturation below 20%. Participants will be randomly assigned to receive either oral sucrosomial iron or a placebo. The sucrosomial iron is given once daily with added vitamin C to help absorption, with dosage based on hemoglobin levels and body weight, over 24 weeks. The placebo pills match the active treatment in appearance and dosing schedule but lack sucrosomial iron and vitamin C. This is a phase 4, quadruple-blind study comparing these two groups. Throughout the study, participants will undergo assessments including the six-minute walk test and quality of life questionnaires at 12 and 24 weeks. Additional evaluations include bone metabolism, iron levels, oxidative stress, heart function measures, and clinical event tracking. Safety and effectiveness will be monitored closely, with the primary outcomes focused on exercise distance and quality of life improvements after 12 weeks of treatment.

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