Trial reportEuropean journal of heart failure2025
Intravenous ferric carboxymaltose in heart failure with iron deficiency (FAIR-HF2 DZHK05 trial): Sex-specific outcomes.
Trial report in European journal of heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036462 (Ferric Carboxymaltose Assessment of Morbidity and Mortality in Patients With IRon Deficiency and Chronic Heart Failure), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Ferric Carboxymaltose Assessment of Morbidity and Mortality in Patients With IRon Deficiency and Chronic Heart Failure
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Intravenous ferric carboxymaltose in patients with heart failure and iron deficiency: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.ESC heart failure · 2026Pooled it
- Landmark clinical trials shaping contemporary guideline-directed medical therapy for heart failure.ESC heart failure · 2026Review
- Comment on 'integrating systemic inflammation and liver biomarkers: prognostic implications of the ferritin index in heart failure'.Annals of medicine · 2025Article
- Iron Deficiency in Heart Failure: Cellular Mechanisms and Therapeutic Implications.Journal of cardiovascular development and disease · 2025Review
Corrections and comments
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Authors and funding
50 authors.
Funding
Abstract
aimsIntravenous iron has emerged as a guideline-recommended therapy in patients with heart failure and iron deficiency, but the potential sex-related differences in efficacy are unknown. We aimed to assess sex-specific outcomes in the Intravenous Iron in Patients with Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality (FAIR-HF2-DZHK05) trial. METHODS AND
resultsFAIR-HF2 included 1105 heart failure patients with a left ventricular ejection fraction ≤45% and iron deficiency. A total of 368 women (mean age 68.7 ± 13.0 years) and 737 men (mean age 70.5 ± 11.0 years) were randomized to intravenous ferric carboxymaltose or placebo. The three primary endpoints were (i) time to cardiovascular death or first heart failure hospitalization, (ii) total heart failure hospitalizations, and (iii) time-to-first event of cardiovascular death or heart failure hospitalization only in patients with transferrin saturation <20% at baseline. The hazard ratio (HR) for the first primary outcome was 1.07 (95% confidence interval [CI] 0.63-1.82, p = 0.80) in women and 0.74 (95% CI 0.57-0.95, p = 0.016) in men, while the rate ratios (RRs) for the second primary outcome were 1.06 (95% CI 0.55-2.05, p = 0.86) and 0.79 (95% CI 0.58-1.08, p = 0.136), respectively, and the HRs for the third primary outcome event were 1.21 (95% CI 0.62-2.36, p = 0.58) and 0.73 (95% CI 0.55-0.97, p = 0.028), respectively. Regarding safety outcomes, the HR for all-cause mortality was 1.46 (95% CI 0.78-2.76, p = 0.24) in women, suggesting increased mortality risk under iron supplementation, in contrast to 0.86 (95% CI 0.64-1.16, p = 0.33) in men (p for interaction = 0.13).
conclusionsThis analysis indicates relevant differential efficacy of intravenous iron in heart failure across both sexes. While men receiving ferric carboxymaltose experienced a clinically relevant reduction in cardiovascular death and heart failure hospitalizations, women did not derive similar benefits. The results are clinically relevant and prompt validation in other large outcome trials of intravenous iron supplementation in heart failure. CLINICAL
trial registrationClinicalTrials.gov NCT03036462.
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