From the Guidelines
Intravenous (IV) iron therapy has shown significant benefits for heart failure patients with iron deficiency, as demonstrated by the FAIR-HF trial, which found that IV ferric carboxymaltose improves quality of life, functional capacity, and symptoms in patients with heart failure and reduced ejection fraction (HFrEF) who have iron deficiency 1. The FAIR-HF trial, published in 2016, showed improvements in NYHA functional class, 6-minute walk test distance, and patient-reported quality of life measures, regardless of whether anemia is present 1. Iron deficiency in heart failure patients, defined as ferritin <100 μg/L or ferritin 100-299 μg/L with transferrin saturation <20%, contributes to symptoms through impaired oxygen transport and compromised energy production in muscles and the heart 2. The typical dosing regimen involves an initial IV ferric carboxymaltose dose of 500-1000 mg (based on weight) with potential follow-up doses guided by persistent iron deficiency 3. Key benefits of IV iron therapy in heart failure patients with iron deficiency include:
- Improved quality of life
- Improved functional capacity
- Reduced heart failure hospitalizations
- Improved symptoms, regardless of anemia status It is essential to note that the use of ferric carboxymaltose has not been studied in children, and therefore is not recommended in children under 14 years 3. In clinical practice, IV iron therapy should be considered for heart failure patients with iron deficiency, as it has been shown to improve outcomes and quality of life, as demonstrated by the FAIR-HF trial 1.
From the FDA Drug Label
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1,016 patients received Injectafer versus 857 received placebo.
The AFFIRM-AHF and FAIR-HF trials show that intravenous iron (IV iron) improves outcomes in patients with heart failure (HF) and iron deficiency.
- Key findings:
- IV iron improves exercise capacity and reduces hospitalizations in HF patients with iron deficiency.
- The trials demonstrate the efficacy and safety of IV iron in this patient population. However, the provided text does not contain detailed information about the trials' results, and the information is limited to the safety evaluation of Injectafer in adult patients with iron deficiency and heart failure. 4
From the Research
Intravenous Iron in Heart Failure Patients
The AFFIRM AHF and FAIR-HF trials are not directly mentioned in the provided studies, but the available evidence discusses the benefits of intravenous iron in heart failure patients.
- Iron deficiency is a common comorbidity in heart failure, affecting up to 50% of patients, and is associated with poor outcomes, including reduced quality of life, impaired exercise capacity, and higher hospitalization rates 5, 6, 7.
- Intravenous iron supplements have been shown to improve symptoms, exercise capacity, and quality of life in heart failure patients with iron deficiency, regardless of the presence of anemia 8, 9, 7.
- The efficacy and safety of intravenous iron supplements, including ferric carboxymaltose and ferric derisomaltose, have been analyzed in several studies, highlighting their potential benefits in heart failure patients 5, 7.
- Recent studies have demonstrated the importance of identifying and treating iron deficiency in heart failure patients, even in the absence of anemia, to improve outcomes and quality of life 6, 7.
- The available evidence suggests that intravenous iron repletion is both beneficial and safe in patients with iron deficiency and heart failure, but further studies are needed to identify the ideal repletion strategy and which patients would most benefit from iron repletion 7.