N Engl J Med 2009;361:2436–2448

“Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with IV iron (FCM) would improve symptoms in patients who had HF, reduced LVEF, and ID, either with or without anemia. METHODS: We enrolled 459 patients with CHF of NYHA functional class II or III, a LVEF of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation was <20%), and a Hb level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of IV (FCM) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at Week 24. Secondary end points included the distance walked in 6 minutes and the health-related QoL. RESULTS: Among the patients receiving FCM, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% CI, 1.75 to 3.61). Among the patients assigned to FCM, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with in the distance on the 6-minute walk test and QoL assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. CONCLUSIONS: Treatment with IV FCM in patients with CHF and ID, with or without anemia, improves symptoms, functional capacity, and QoL; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780). Copyright 2009 Massachusetts Medical Society”