"Iron Supplementation in Heart Failure with Reduced Ejection Fraction and Iron Deficiency".

The New England Journal of Medicine. 2009. 361:2436-2448.
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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

Clinical Question

In patients with chronic heart failure, reduced left ventricular ejection fraction, and iron deficiency, does intravenous iron supplementation improve symptoms and quality of life?

Bottom Line

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.

Major Points

Guidelines

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.

Design

Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial.

Population

- 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

Interventions

- Ferric carboxymaltose: 200 mg intravenous iron weekly until iron repletion, then monthly for maintenance
- Saline (Placebo): Same regimen as ferric carboxymaltose

Outcomes

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)

Secondary Outcomes
- 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

Funding

Sponsored by Vifor Pharma.

Further Reading

- Full text available at NEJM.org
- ClinicalTrials.gov number, NCT00520780