Heart failure & cardiomyopathies
Intravenous ferric carboxymaltose in patients with heart failure and iron deficiency: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Authors' conclusion
Intravenous FCM in HF patients is associated with reduced risk of adverse cardiovascular events and improved functional capacity. Further trials are needed to clarify its long-term survival impact.
Study context
- Population
- Heart failure (HF) patients with iron deficiency (ID)
- Participants
- 6,493 patients11 randomized controlled trials (RCTs)
- Comparison
- Ferric carboxymaltose (FCM) with placebo or standard care
- FCMn = 3,329
- Controln = 3,164reference
- Outcome
- composite of:
- Recurrent hospitalizations for heart failure (HHF)
- Cardiovascular (CV) death
- Follow-up
- 1-year and complete
Methodological detailsrandom-effects model
- Random-effects model
Pooled result
As reported in the abstract
FCM vs controlRelative risk (95% CI)
1-year
0.73(0.62–0.85)
Over maximum follow-up
0.80(0.68–0.94)
Further pooled results
| Outcome | RR (95% CI) | |
|---|---|---|
| Recurrent HHF · 1-year and complete follow-upFCMvs control | 0.69 (0.57–0.84) | |
| Recurrent HHF · 1-year and complete follow-upFCMvs controlComplete follow-up | 0.75 (0.60–0.94) | |
| All-cause and CV mortality · 1-yearAll-cause mortality (time point not stated) — FCMvs control | 0.86 (0.74–1.00) | |
| All-cause and CV mortality · 1-yearFCMvs controlCV mortality at 1-year | 0.86 (0.72–1.02) | |
| 0.512Relative risk (log scale) |
| Outcome | MD (m) (95% CI) | |
|---|---|---|
| 6-minute walk test performance | 29.19 (11.95–46.43) | |
| −200204060Difference, m (linear scale) |
- All-cause and cardiovascular (CV) mortality: CV mortality at 1-year — FCM vs control: RR 0.86 (95% CI 0.72-1.02)
- All-cause and CV mortality: trend towards reduced; effect attenuated over longer follow-up
Baseline characteristics
- Mean age
- 66.7 ± 10.6 years
- Women
- 34.4%
- Mean left ventricular ejection fraction
- 33.7 ± 8.8%
- Mean haemoglobin
- 12.4 ± 1.8 g/dL
- Mean transferrin saturation
- 18.9 ± 10.1%
Original publication
Intravenous ferric carboxymaltose in patients with heart failure and iron deficiency: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. ESC Heart Fail. Published 8 January 2026. doi:10.
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