Abstract
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. 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). 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%. http//www.clinicaltrials.gov identifier NCT03662789.
Highlights
We recently screened a population of 380 patients transplanted in Norway, and we found iron deficiency, defined as ferritin
Men and women were tested at a resistance of 80 kg and 40 kg, Brautaset Englund et al Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients respectively, and measurements were recorded before the treadmill test
The baseline data were well balanced between the study arms except for renal function, which was marginally better in the ferric derisomaltose group (Table 1)
Summary
Men and women were tested at a resistance of 80 kg and 40 kg, Brautaset Englund et al Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients respectively, and measurements were recorded before the treadmill test. If values were too skewed for transformation, we used the Mann-Whitney U test to analyze the between-group difference in the change from baseline to follow-up. We calculated that 44 patients in each treatment arm would provide 80% power at an a of 5%, given a mean between-group difference in oxygen consumption of 1.5 ml/kg/min and a repeat measurement standard deviation of 2.5 ml/kg/min.[16] To compensate for dropouts, we enrolled 102 patients. When a patient was enrolled and assigned a trial number, another thirdparty nurse opened the corresponding envelope and prepared either placebo or ferric derisomaltose according to the information on the card. All study investigators were blinded and did not participate in treatment allocation or administration of the study drug
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