Heart failure & cardiomyopathiesRandomised controlled trial
Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- stopped early for slow recruitment
- Stopped because of slow recruitment after 39 patients included (median age 80 years, 62% women)
Authors' conclusion
In patients with HFpEF and markers of ID, intravenous FCM improved 6MWTD and was associated with fewer serious adverse events.
Study context
- Population
- Symptomatic heart failure with preserved ejection fraction (HFpEF) with iron deficiency (serum ferritin < 100 ng/mL or ferritin 100–299 ng/mL with transferrin saturation < 20%)200 planned
- Participants
- 39 participants
- Comparison
- IV ferric carboxymaltose vs placebo
- Primary endpoint
- Change in 6-min walking test distance (6MWTD) from baseline
- Follow-up
- Week 24
Primary result
Change in 6MWTD
Least square mean difference
49 m
95% CI 5–93
P = 0.029
FCM vs Placebo
least square mean difference 49 m (95% CI 5–93); P = 0.029
As reported in the abstract
Secondary outcomes
NYHA class, patient global assessment, health-related quality of life (QoL)
- Not significantly different between groups
Safety
events
| Outcome | FCM | Placebo | rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious adverse events | 5 | 19 | 0.27 (0.07–0.96) | P = 0.043 | |
| 0.050.21520Rate ratio (log scale) |
events
| Outcome | FCM | Placebo | Estimate | P value |
|---|---|---|---|---|
| Total adverse events | 76 | 114 |
Original publication
Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial. Eur Heart J. Published 26 August 2024. doi:10.1093/eurheartj/ehae479
Summarised from the published abstract; every number is checked against it