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Intravenous ferric carboxymaltose for iron deficiency in heart failure patients: A meta-analysis with trial
Laila Shalabi1, Ahmed Ibrahim2, Shrouk Ramadan3
1Faculty of Medicine, Gharyan University, Gharyan, Libya.
Insights
Intravenous ferric carboxymaltose (FCM) significantly lowers heart failure hospitalizations and cardiovascular death in patients with iron deficiency. This treatment supports its use as a targeted therapy for improving heart failure outcomes.
Area of Science:
- Cardiology
- Pharmacology
- Internal Medicine
Background:
- Iron deficiency affects 33-50% of chronic heart failure patients, correlating with poorer prognoses.
- Intravenous (IV) ferric carboxymaltose (FCM) is a potential therapeutic agent for this population.
- Assessing FCM's impact on heart failure outcomes is crucial for clinical practice.
Purpose of the Study:
- To evaluate the efficacy of IV ferric carboxymaltose (FCM) in patients with chronic heart failure and iron deficiency.
- To determine the effect of FCM on key heart failure-related endpoints, including hospitalizations and mortality.
Main Methods:
- A systematic literature review of randomized controlled trials (RCTs) was conducted across major databases (PubMed, Scopus, Cochrane Library, Web of Science) up to May 2025.
- Pooled risk ratios (RRs) were calculated using a fixed-effect model for primary outcomes (heart failure hospitalization or cardiovascular death), total heart failure hospitalizations, and total all-cause hospitalizations.
- Trial sequential analysis (TSA) was employed to validate the robustness and statistical power of the findings.
Main Results:
- Nine RCTs involving 7491 patients demonstrated that FCM significantly reduced the risk of heart failure hospitalization or cardiovascular death (RR 0.89, P=0.0016).
- FCM also significantly lowered heart failure hospitalizations (RR 0.82, P<0.0001) and cardiovascular death (RR 0.89, P=0.0384).
- No significant difference was observed in total all-cause hospitalizations (RR 0.93, P=0.0830), though TSA confirmed conclusive evidence for the primary outcome.
Conclusions:
- Ferric carboxymaltose (FCM) effectively reduces heart failure hospitalizations and cardiovascular death in patients with iron-deficient heart failure.
- While FCM does not significantly impact all-cause hospitalization rates, its benefits on specific cardiovascular outcomes support its role as a targeted therapeutic strategy.
- The findings underscore the importance of addressing iron deficiency in heart failure management.
Background:
Iron deficiency is present in roughly one-third to one-half of patients with chronic heart failure and is associated with worse outcomes. In this study, we aim to assess the impact of intravenous (IV) ferric carboxymaltose (FCM) administration on heart failure outcomes.
Methods:
We performed a comprehensive literature search of PubMed, Scopus, Cochrane Library, and Web of Science for randomized controlled trials (RCTs) up to May 2025. The outcomes of interest, including first heart failure hospitalization or cardiovascular death (primary outcome), total heart failure hospitalizations, and total all-cause hospitalization, were estimated using a fixed-effect model and reported as pooled risk ratios (RRs). Trial sequential analysis (TSA) was conducted to assess the robustness of the findings and estimate the required information size.
Results:
Nine RCTs were included, comprising 7491 patients. Compared to placebo, FCM significantly reduced the risk of hospitalization due to heart failure or cardiovascular death (RR 0.89, 95 % CI 0.83-0.96; P = 0.0016). Additionally, FCM lowered the risk of heart failure hospitalizations (RR 0.82, 95 % CI 0.77-0.87; P < 0.0001) and decreased the risk of cardiovascular death (RR 0.89, 95 % CI 0.80-0.99; P = 0.0384). However, there was no significant difference in total all-cause hospitalization between the groups (RR 0.93, 95 % CI 0.85-1.01; P = 0.0830). TSA demonstrated conclusive evidence for the primary outcome.
Conclusion:
FCM reduces the risk of heart failure hospitalizations, cardiovascular hospitalizations, and cardiovascular death in iron-deficient heart failure patients, although it does not impact all-cause hospitalization, thereby supporting its utility as a targeted therapeutic strategy.
Prospero Id:
CRD420251062092.
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