FAIR-HF2 DZHK05
Trial question
What is the effect of ferric carboxymaltose in patients with HF and iron deficiency?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 1105
1105 patients (368 female, 737 male).
Inclusion criteria: patients with HF and iron deficiency.
Key exclusion criteria: known hypersensitivity to any component of ferric carboxymaltose; ferritin concentration ≥ 300 mcg/L or hemoglobin concentration < 9.5 g/dL; history of treatment with an EPO-stimulating agent; receipt of any intravenous iron or blood transfusion within the past 6 weeks.
Interventions
N=558 ferric carboxymaltose (intravenous dose of up to 2,000 mg followed by 500 mg every 4 months).
N=547 placebo (matching intravenous saline placebo).
Primary outcome
Incidence of time to first hospitalization for heart failure or CV death in patients with transferrin saturation < 20%
18.9
25.6
25.6/100 py
19.2/100 py
12.8/100 py
6.4/100 py
0.0/100 py
Ferric
carboxymaltose
Placebo
No significant
difference ↔
No significant difference in the incidence of time to first hospitalization for HF or CV death in patients with transferrin saturation < 20% (18.9/100 py vs. 25.6/100 py; HR 0.79, 95% CI 0.61 to 1.02).
Secondary outcomes
Significant decrease in the incidence of time to CV death or first HF hospitalization (16.7/100 py vs. 21.9/100 py; HR 0.79, 95% CI 0.63 to 0.99).
No significant difference in the incidence of hospitalizations for HF (26.4/100 py vs. 33.4/100 py; RR 0.8, 95% CI 0.6 to 1.06).
No significant difference in mean improvement in 6-minute walk test at 12 months (27.2 m vs. 19.7 m; MD 10.7, 95% CI -1.44 to 22.9).
Safety outcomes
No significant difference in all-cause mortality and CV death at 36 months.
Conclusion
In patients with HF and iron deficiency, ferric carboxymaltose was not superior to placebo with respect to the incidence of time to first hospitalization for HF or CV death in patients with transferrin saturation < 20%.
Reference
Stefan D Anker, Tim Friede, Javed Butler et al. Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency: The FAIR-HF2 DZHK05 Randomized Clinical Trial. JAMA. 2025 Mar 30. Online ahead of print.
Open reference URL