IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches

What this Trial Is About

Researchers are studying adults with congestive heart failure who have low iron levels, specifically those with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and transferrin saturation below 20 percent. The study aims to compare two iron treatments—intravenous (IV) iron and oral (PO) iron—to see which one better improves walking distance, symptoms, and quality of life, while also evaluating safety and risks such as hospital readmissions and mortality. Participants will be randomly assigned to receive either intravenous ferric carboxymaltose or oral ferrous sulfate. Those in the IV group will get a one-time 1-gram infusion during a hospital stay and possibly a second dose at 6 weeks depending on their weight. The oral group will take one capsule every 48 hours for 12 weeks. Follow-up visits include a 6-minute walk test, symptom surveys, and blood tests to measure iron levels at 12 weeks. During the trial, participants will attend clinic visits for treatment and assessments, including tracking walking distance, symptoms, quality of life, and iron stores. Safety will be monitored by reviewing adverse events, heart failure readmissions, and mortality. The main measurement is the change in 6-minute walk distance from baseline to 12 weeks. The study is expected to help guide doctors on the best iron therapy approach for people with heart failure.

IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches