This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) for patients in heart failure with iron deficiency.
To determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction. (HEART-FID)
“Anemia is a well-recognized co-morbidity with heart failure and is associated with higher morbidity and mortality. However, treatment attempts have been met with mixed results. Current understanding is that iron deficiency, even before profound anemia develops, is a precursor and thus intervening at earlier stages with IV iron could prevent progressive anemia and the resultant adverse outcomes. This trial aims to prove this very hypothesis.” Shelley Hall, MD, principal investigator.
Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria for the HEART-FID study can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03037931?term=HEART-FID&rank=1
Amanda Doss, Amanda.Doss@bswhealth.org, 214.865.2419.