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

ESC Heart FailPublished

  • systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
  • random-effects model
+1 more
  • random-effects model

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)Ferric carboxymaltose (FCM) 3,329 · control 3,164
Participants
6,493 Eleven randomized controlled trials (RCTs)
Comparison
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

Pooled result

As reported in the abstract

composite of:
  • Recurrent hospitalizations for heart failure (HHF)
  • Cardiovascular (CV) death
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

OutcomeRR (95% CI)
Recurrent HHF · 1-year and complete follow-up — FCM vs control0.69 (0.57–0.84)
Recurrent HHF · 1-year and complete follow-up — FCM vs control · complete follow-up0.75 (0.60–0.94)
All-cause and CV mortality · 1-year — All-cause mortality (time point not stated) — FCM vs control0.86 (0.74–1.00)
All-cause and CV mortality · 1-year — FCM vs control · CV mortality at 1-year0.86 (0.72–1.02)
OutcomeMD (m) (95% CI)
6-minute walk test performance29.19 (11.95–46.43)
  • 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:10.1093/eschf/xvaf018

Summarised from the published abstract; every number is checked against it