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Intravenous iron supplement for iron deficiency in cardiac transplant recipients (IronIC): A randomized clinical
Kristine V Brautaset Englund1, Charlotte M Østby2, Katrine Rolid1
1Department of Cardiology, Oslo University Hospital, Rikshospitalet, Norway; University of Oslo, Oslo, Norway; K.G. Jebsen Cardiac Research Center and Center for Heart Failure Research, Faculty of Medicine, University of Oslo, Oslo, Norway.
Insights
Intravenous iron therapy did not improve exercise capacity in most heart transplant patients. However, it did benefit a subgroup with very low baseline iron levels, improving their quality of life.
Area of Science:
- Cardiology
- Transplantation Medicine
- Nutritional Science
Background:
- Heart transplant recipients often experience reduced exercise capacity.
- Preserved graft function does not always correlate with improved physical performance.
Purpose of the Study:
- To investigate if intravenous iron therapy can enhance peak oxygen consumption in heart transplant recipients.
- To assess the impact of iron supplementation on exercise capacity and quality of life in this population.
Main Methods:
- A randomized, placebo-controlled, double-blind trial involving 102 heart transplant recipients.
- Patients received either ferric derisomaltose (intravenous iron) or a placebo.
- Cardiopulmonary exercise tests and iron status were assessed at baseline and 6-month follow-up.
Main Results:
- Overall, intravenous iron did not significantly improve peak oxygen consumption compared to placebo.
- A significant improvement in peak oxygen consumption was observed in patients with baseline ferritin <30 µg/liter.
- Iron stores were effectively restored with intravenous iron, and quality of life improved significantly in the treatment group.
Conclusions:
- Intravenous iron therapy is not broadly effective for improving exercise capacity in heart transplant recipients with mild to moderate iron deficiency.
- Subgroup analysis suggests potential benefits for patients with severe iron deficiency (ferritin <30 µg/liter).
- Iron repletion improved quality of life and iron status, irrespective of the primary endpoint.
Aims:
Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous iron therapy would improve peak oxygen consumption in these patients.
Methods And Results:
This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin <100 µg/liter or 100 to 300 µg/liter, in combination with transferrin saturation of <20%, and hemoglobin level >100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous iron group vs 30 in the placebo group (p = 0.39).
Conclusion:
Intravenous iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%.
Trial Registration Number:
http//www.clinicaltrials.gov identifier NCT03662789.
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