28 Aug 2023 • This double-blind, randomized trial aimed to evaluate the effects of ferric carboxymaltose therapy on patients with heart failure characterized by reduced ejection fraction and iron deficiency. Patients were assigned either ferric carboxymaltose or placebo in addition to standard heart failure therapy. The primary outcome was a composite of death within 12 months, heart failure hospitalizations within 12 months, or change in the 6-minute walk distance from baseline to 6 months. Out of 3065 enrolled patients, 1532 received ferric carboxymaltose and 1533 received placebo. By month 12, death occurred in 8.6% of the ferric carboxymaltose group and 10.3% of the placebo group. Hospitalizations for heart failure by month 12 were 297 and 332, respectively. The change in the 6-minute walk distance was 8±60 meters in the ferric carboxymaltose group and 4±59 meters in the placebo group (p=0.02). Repeated ferric carboxymaltose dosing seemed safe with an acceptable adverse-event profile. The occurrence of serious adverse events was similar in both groups. In conclusion, among ambulatory patients with heart failure and reduced ejection fraction plus iron deficiency, ferric carboxymaltose therapy did not show a significant difference compared to placebo regarding the composite outcome of death, heart failure hospitalizations, or 6-minute walk distance. Source: NEJM | Read full story