6/28/23, 10:33 PM FAIR-HF Pathway Feedback Search Clinical Topics Home Studies FAIR HF FAIR HF Disease Disease Heart failure Iron deficiency anemia Trial question What is the role of intravenous ferric carboxymaltose in patients with chronic HF and iron deficiency? Study design Multi-center Double blinded RCT Population Characteristics of study participants 53.0% female N = 459 47.0% male 459 patients (244 female, 215 male) Inclusion criteria: patients with chronic HF, reduced LVEF, and iron deficiency, with or without anemia Key exclusion criteria: uncontrolled hypertension, other clinically significant heart disease, inflammation, or clinically significantly impaired liver or renal function Interventions N=304 ferric carboxymaltose (200 mg of intravenous iron weekly) N=155 placebo (intravenous saline weekly) Primary outcome Percentage of patients achieving good or moderate improvement on self-reported Patient Global Assessment at 24 weeks 50.0 % 50 https://web.pathway.md/studies/rec1abS95oy1jDBiW 1/2 6/28/23, 10:33 PM FAIR-HF Pathway 37.5 % 28 25.0 % Significant increase 12.5 % NNT = 5 0.0 % Ferric carboxymaltose Placebo Significant increase in the percentage of patients achieving good or moderate improvement on the self-reported Patient Global Assessment at 24 weeks (50% vs. 28%; OR 2.51, 95% CI 1.75 to 3.61) Secondary outcomes Significant increase in NYHA functional class I or II at 24 weeks (47% vs. 30%; OR 2.4, 95% CI 1.55 to 3.71) Safety outcomes No significant differences in rates of death, adverse events, and serious adverse events. Conclusion In patients with chronic HF, reduced LVEF, and iron deficiency, with or without anemia, ferric carboxymaltose was superior to placebo with respect to the percentage of patients achieving good or moderate improvement on the self-reported Patient Global Assessment at 24 weeks. Reference Anker SD, Comin Colet J, Filippatos G et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. Open reference URL https://web.pathway.md/studies/rec1abS95oy1jDBiW 2/2