Comparing High-Dose and Low-Dose Intravenous Ferric Derisomaltose for Treating Iron Deficiency in Adults with Chronic Heart Failure

What this Trial Is About

Researchers are evaluating whether a higher dose of intravenous IV iron repletion improves exercise capacity more than a lower dose in patients with chronic heart failure and iron deficiency. This phase 4 randomized, open-label, blind endpoint study aims to compare the effects of high-dose versus low-dose IV iron therapy on peak oxygen uptake over 12 months. The study addresses the uncertainty around optimal iron repletion targets in this patient group, with previous trials showing varied dosing strategies and outcomes. Participants will be randomly assigned to receive either a high-dose or low-dose IV iron regimen using ferric derisomaltose. After initial treatment, iron levels serum ferritin and transferrin saturation will be checked every three months to guide further dosing. The high-dose group will continue dosing until ferritin exceeds 700 ngmL or transferrin saturation exceeds 40%, while the low-dose group receives iron if ferritin falls below 100 ngmL or ferritin is 100-300 ngmL with transferrin saturation below 20%. Infusions are administered over 15 to 30 minutes depending on dose size. Participants will undergo assessments including cardiopulmonary exercise testing at randomization and follow-up visits over one year. Researchers will measure changes in peak oxygen uptake, heart rate, walking distance, muscle and heart iron content by MRI, quality of life, cognitive function, heart function, and hospitalization rates. Safety and efficacy will be monitored throughout, with the study concluding after 52 weeks of follow-up to evaluate the impact of iron dosing on exercise and heart failure outcomes.

The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency