Heart failure & cardiomyopathies
Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency: The FAIR-HF2 DZHK05 Randomized Clinical Trial
Authors' conclusion
In patients with heart failure and iron deficiency, ferric carboxymaltose did not significantly reduce the time to first heart failure hospitalization or cardiovascular death in the overall cohort or in patients with a transferrin saturation less than 20%, or reduce the total number of heart failure hospitalizations vs placebo.
Study context
- Population
- Patients with HF (LVEF ≤45%) and iron deficiency (ferritin <100 ng/mL, or 100–299 ng/mL if transferrin saturation <20%)
- Participants
- 1,105 patients
- Comparison
- IV ferric carboxymaltose vs placebo
- Ferric carboxymaltosen = 558
- Placebon = 547reference
- Primary endpoint
- Three primary end points: (1) time to CV death or first HF hospitalization; (2) total HF hospitalizations; (3) time to CV death or first HF hospitalization in patients with transferrin saturation <20% (Hochberg procedure)
- Follow-up
- Through (median 16.6 months)
Methodological detailsmulticentre, placebo-controlled, 70 sites in 6 European countries
- Multicentre
- Placebo-controlled
- 70 sites in 6 European countries
Primary result
As reported in the abstract
Ferric carboxymaltose
- CV death or first HF hospitalization (patients)
- 141
- Total HF hospitalizations
- 264
- CV death or first HF hospitalization, TSAT <20% (patients)
- 103
Placebo
- CV death or first HF hospitalization (patients)
- 166
- Total HF hospitalizations
- 320
- CV death or first HF hospitalization, TSAT <20% (patients)
- 128
CV death or first HF hospitalization (patients)
Ferric carboxymaltose141
Placebo166
Total HF hospitalizations
Ferric carboxymaltose264
Placebo320
CV death or first HF hospitalization, TSAT <20% (patients)
Ferric carboxymaltose103
Placebo128
Ferric carboxymaltose vs PlaceboEstimate (95% CI)P value
First primary: CV death or first HF hospitalization
HR 0.79(0.63–0.99)
P = 0.04Second primary: total HF hospitalizations
rate ratio 0.80(0.60–1.06)
P = 0.12Third primary: TSAT <20%
HR 0.79(0.61–1.02)
P = 0.07Safety
≥1 serious adverse event
P = 0.61
Original publication
Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency: The FAIR-HF2 DZHK05 Randomized Clinical Trial. JAMA. Published 10 June 2025. doi:10.
Summarised from the published abstract; every number is checked against it