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Heart failure & cardiomyopathiesSecondary analysis

Intravenous Ferric Carboxymaltose in Heart Failure with Iron Deficiency (FAIR-HF2 DZHK05 trial): Sex-Specific Outcomes

Eur J Heart FailPublished

  • Secondary analysis of the FAIR-HF2 randomised trial
  • sex-specific subgroup analysis
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Authors' conclusion

While men receiving ferric carboxymaltose experienced a clinically relevant reduction in cardiovascular death and heart failure hospitalizations, women did not derive similar benefits.

Study context

Population
HF patients with LVEF ≤45% and iron deficiency (368 women, 737 men)368 women · 737 men
Participants
1,105 patients
Comparison
IV ferric carboxymaltose vs placebo, by sex
Primary endpoint
Three primary endpoints: (i) time to CV death or first HF hospitalization; (ii) total HF hospitalizations; (iii) time to first CV death or HF hospitalization in patients with transferrin saturation <20% at baseline

Primary result

As reported in the abstract

CV death or first HF hospitalization; total HF hospitalizations; CV death or HF hospitalization in TSAT <20% (three primary endpoints), by sex
Each group vs placeboEstimate (95% CI)P value
Womenfirst primary outcome (CV death or first HF hospitalization); ferric carboxymaltose vs placebo
HR 1.07(0.63–1.82)
P = 0.80
Menfirst primary outcome (CV death or first HF hospitalization); ferric carboxymaltose vs placebo
HR 0.74(0.57–0.95)
P = 0.016
Womensecond primary outcome (total HF hospitalizations); rate ratio
RR 1.06(0.55–2.05)
P = 0.86
Mensecond primary outcome (total HF hospitalizations); rate ratio
RR 0.79(0.58–1.08)
P = 0.136
Womenthird primary outcome (CV death or HF hospitalization, TSAT <20%)
HR 1.21(0.62–2.36)
P = 0.58
Menthird primary outcome (CV death or HF hospitalization, TSAT <20%)
HR 0.73(0.55–0.97)
P = 0.028

Further findings

OutcomeHR (95% CI)P value
All-cause mortality (safety outcome), by sex — Women vs Placebo · ferric carboxymaltose vs placebo1.46 (0.78–2.76)P = 0.24
All-cause mortality (safety outcome), by sex — Men vs Placebo · ferric carboxymaltose vs placebo0.86 (0.64–1.16)P = 0.33
  • All-cause mortality (safety outcome), by sex: p for interaction = 0.13

Original publication

Intravenous Ferric Carboxymaltose in Heart Failure with Iron Deficiency (FAIR-HF2 DZHK05 trial): Sex-Specific Outcomes. Eur J Heart Fail. Published 31 July 2025. doi:10.1002/ejhf.3742
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Summarised from the published abstract; every number is checked against it