"Iron Supplementation in Heart Failure with Reduced Ejection Fraction and Iron Deficiency".
Links to original sources: Wiki Journal Post Full Journal Article
The New England Journal of Medicine. 2009. 361:2436-2448. PubMed•Full text•PDF
Contents 1Clinical Question 2Bottom Line 3Major Points 4Guidelines 5Design 6Population 6.1Inclusion Criteria 6.2Exclusion Criteria 6.3Baseline Characteristics 7Interventions 8Outcomes 8.1Primary Outcomes 8.2Secondary Outcomes 9Funding 10Further Reading
In patients with chronic heart failure, reduced left ventricular ejection fraction, and iron deficiency, does intravenous iron supplementation improve symptoms and quality of life?
In patients with chronic heart failure, reduced ejection fraction, and iron deficiency, intravenous iron (ferric carboxymaltose) supplementation improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable.
Iron deficiency impairs oxygen transport and utilization, potentially exacerbating symptoms in patients with heart failure. The FAIR-HF trial investigated the effects of intravenous iron supplementation on patients with chronic heart failure and iron deficiency, with or without anemia, to determine whether it confers symptomatic benefits.
As of the latest updates, specific guidelines reflecting the results of this trial were not detailed, but might consider intravenous iron supplementation in heart failure patients with confirmed iron deficiency.
Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial.
- Total number of participants: 459 - Inclusion Criteria: Ambulatory patients with heart failure of NYHA functional class II or III, left ventricular ejection fraction ≤40% (NYHA class II) or ≤45% (NYHA class III), iron deficiency (ferritin <100 μg per liter or 100-299 μg per liter if transferrin saturation <20%), and hemoglobin 95-135 g per liter - Exclusion Criteria: Uncontrolled hypertension, significant other heart disease, inflammation, or significantly impaired hepatic or renal function - Baseline Characteristics: Demographically similar groups with respect to clinical and laboratory characteristics
- Ferric carboxymaltose: 200 mg intravenous iron weekly until iron repletion, then monthly for maintenance - Saline (Placebo): Same regimen as ferric carboxymaltose
Primary Outcomes - 50% of patients in the ferric carboxymaltose group reported improvements compared to 28% in the placebo group (odds ratio for improvement, 2.51; 95% CI, 1.75 to 3.61) according to the Patient Global Assessment at week 24 - 47% in the ferric carboxymaltose group had an NYHA functional class I or II at week 24 compared to 30% in placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71)
- Improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments - Rates of death, adverse events, and serious adverse events were similar between groups
Sponsored by Vifor Pharma.
- Full text available at NEJM.org - ClinicalTrials.gov number, NCT00520780