IV Iron Therapy for Heart Failure and Iron Deficiency

(INFUSE-HFpEF Trial)

This trial tests a new treatment called ferric derisomaltose, an intravenous iron therapy. It aims to help older adults with heart failure with preserved ejection fraction (a type of heart failure where the heart pumps well but is stiff) and iron deficiency. Participants will receive either the iron treatment or a placebo (a non-active substance) to determine if it improves their condition. Suitable candidates have experienced heart failure-related hospitalizations in the past year and can walk independently. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Research has shown that ferric derisomaltose is generally safe for people with heart failure and iron deficiency. One study reported no serious safety issues, such as major reactions during infusion or severe side effects, indicating that patients did not experience severe reactions to the treatment. Another study found that ferric derisomaltose was well-tolerated, with most patients handling the treatment without significant problems.

Ferric derisomaltose is unique because it offers a new option for treating heart failure in patients with iron deficiency through intravenous iron supplementation. Unlike traditional oral iron supplements that can take longer to show effects and often cause gastrointestinal side effects, ferric derisomaltose is administered directly into the bloodstream, potentially allowing for faster improvement in iron levels and heart function. Researchers are excited about this treatment because it might improve patients' quality of life more rapidly and effectively than current oral iron therapies.

Research has shown that ferric derisomaltose, an IV-administered iron, can improve symptoms in people with heart failure and low iron. In this trial, participants will receive either ferric derisomaltose or a placebo. Some studies suggest that ferric derisomaltose might reduce hospital visits and heart-related deaths for these patients. However, other research indicates it does not outperform standard heart failure treatments. While results are mixed, treating low iron in heart failure patients generally reduces the risk of heart problems. Thus, ferric derisomaltose could be beneficial, but its effectiveness may vary among individuals.¹²³⁴⁶