Primary endpoint just missed for IV ferric carboxymaltose in acute HF
Results of the AFFIRM-AHF trial were announced: the trial just missed statistical significance on the composite primary endpoint of total heart failure hospitalizations and CV death. In the trial, the effect of intravenous ferric carboxymaltose vs. placebo on HF hospitalizations and CV mortality was examined in iron-deficient patients hospitalized for acute HF.
A pre-specified sensitivity analysis on adjustment of COVID-19 impact did show a significant effect of intravenous ferric carboxymaltose on CV mortality and HF hospitalization.
Detailed results of the AFFIRM- AHF trial will be presented at the American Heart Association congress in November this year.
The AFFIRM- AHF trial is a randomized, double-blind, placebo-controlled trial that enrolled 1132 patients with reduced and mid-range ejection fraction (LVEF <50%) and iron deficiency (serum ferritin <100 ng/mL or serum ferritin 100-299 ng/mL with TSAT <20%). Patients were randomized to intravenous ferric carboxymaltose or placebo before discharge from the hospital following an episode of acute HF and followed for 52 weeks. Intravenous ferric carboxymaltose was in general well tolerated without any safety signals.