This article is more than 5 years old. Information may no longer be current.
Phase 3 trial to study IV iron in patients with HFrEF begins enrollment
Click Here to Manage Email Alerts
American Regent, a Daiichi Sankyo company, announced the first patients have been enrolled in a trial studying IV ferric carboxymaltose in individuals with HF with reduced ejection fraction and iron deficiency.
The study, HEART-FID, is a double blind, multicenter, randomized, placebo-controlled study of IV ferric carboxymaltose (Injectafer, American Regent) in patients with HFrEF and iron deficiency, according to a press release issued by the company.
“Iron deficiency affects up to half of all [patients with HF] and is associated with impaired exercise tolerance, and mortality in patients with or without anemia,” Adrian F. Hernandez, MD, MHS, of Duke Clinical Research Institute, said in the release. “HEART-FID has the potential to provide a deeper understanding of how [IV] iron may help patients with [HF] with a low ejection fraction.”
Primary outcomes include death and hospitalization for worsening HF at 12 months and change in 6-minute walk test at 6 months.
The researchers plan to enroll more than 3,000 adults in North America.