Heart failure & cardiomyopathiesRandomised controlled trial
Ferric Carboxymaltose in Heart Failure with Iron Deficiency
- Randomised controlled trial
- double-blind
- placebo-controlled
Authors' conclusion
Among ambulatory patients who had heart failure with a reduced ejection fraction and iron deficiency, there was no apparent difference between ferric carboxymaltose and placebo with respect to the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance.
Study context
- Population
- Ambulatory patients with HF, LVEF ≤40% and iron deficiency
- Participants
- 3,065 patients
- Comparison
- IV ferric carboxymaltose vs placebo, in addition to standard HF therapy
- Ferric carboxymaltosen = 1,532
- Placebon = 1,533reference
- Primary endpoint
- Hierarchical composite of:
- Death within 12 months
- HF hospitalizations within 12 months
- Change from baseline to 6 months in 6-minute walk distance (significance level 0.01)
- Follow-up
- 12 months (death, HF hospitalizations); 6 months (6-minute walk distance)
Primary result
Hierarchical composite
Unmatched win ratio
1.10
99% CI 0.99–1.23
P = 0.02
By group
Ferric carboxymaltose
131 (8.6%)
Death by month 12 · HF hospitalizations by month 12 297 · Mean change in 6-minute walk distance to 6 months 8±60 m (SD)
Placebo
158 (10.3%)
Death by month 12 · HF hospitalizations by month 12 332 · Mean change in 6-minute walk distance to 6 months 4±59 m (SD)
As reported in the abstract
Safety
Serious adverse events during treatment period
Serious adverse events during treatment period
- Similar in the two groups
- Repeated dosing appeared safe with an acceptable adverse-event profile in the majority of patients
Original publication
Summarised from the published abstract; every number is checked against it