Heart failure & cardiomyopathiesRandomised controlled trial
Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency
- Randomised controlled trial
- multicentre
- placebo-controlled
- 70 sites in 6 European countries
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)
Primary result
As reported in the abstract
Ferric carboxymaltose
141
CV death or first HF hospitalization (patients) · Total HF hospitalizations 264 · CV death or first HF hospitalization, TSAT <20% (patients) 103
Placebo
166
CV death or first HF hospitalization (patients) · Total HF hospitalizations 320 · CV death or first HF hospitalization, TSAT <20% (patients) 128
Safety
≥1 serious adverse event
P = 0.61
Original publication
Summarised from the published abstract; every number is checked against it