August 28, 2023- American Regent, Inc. announced results from the phase 3 HEART-FID trial of INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).
Results from the HEART-FID study showed that for adult heart failure patients with stable chronic HFrEF who received intravenous ferric carboxymaltose, there were numerically fewer deaths and hospitalizations for heart failure through 12 months and a modest benefit in the six-minute walking distance (6-MWD) at 6 months compared to placebo. At 12 months, death occurred for 131 patients (8.6%) in the ferric carboxymaltose group and 158 patients (10.3%) in the placebo group; there were 297 and 332 total hospitalizations for heart failure.
“This trial addresses important clinical questions of diagnosing and treating iron deficiency in patients with heart failure at a specified dose regimen of ferric carboxymaltose to reduce rates of death and hospitalization as well as improve function,” said Robert Mentz, MD, Associate Professor in the Department of Medicine at Duke University School of Medicine, and Member of the Duke Clinical Research Institute and Clinical Lead for the trial.