In the Ferric Carboxymaltose in Heart Failure with Iron Deficiency (HEART-FID) trial, 3065 ambulatory patients who had heart failure with reduced ejection fraction (a condition in which the heart is unable to pump out blood effectively) and iron deficiency, were randomized 1:1 to receive an intravenous iron supplementation called ferric carboxymaltose (FCM) or placebo, in addition to standard therapy for heart failure.
The results for this study were presented at the 2023 European Society of Cardiology Congress in Amsterdam, and simultaneously published in the New England Journal of Medicine. The researchers found that outcomes improved for the patients who received FCM, however, the study did not meet the primary endpoint statistical testing threshold mandated by the U.S. regulatory agency (FDA). Nevertheless, the trial did verify the safety of FCM and demonstrated a modest improvement in cardiovascular outcomes when compared with placebo. Further analysis of the data from this study is forthcoming as part of the partnership between the CVC and Duke Clinical Research Institute (DCRI).
“Trials such as HEART-FID demonstrate the ability to do large scale trials, which will change guideline recommendations that were based on smaller and directionally similar trials,” says Dr. Justin Ezekowitz, HEART-FID Steering Committee member and site investigator. “Further work exploring the data will help elucidate which patients derive the greatest benefit from IV iron as we transition this therapy into practice.”