Intravenous iron supplement for iron deficiency in cardiac transplant recipients (IronIC): A randomized clinical trial

被引:13
作者
Englund, Kristine V. Brautaset [1 ,2 ,3 ,4 ]
Ostby, Charlotte M. [1 ]
Rolid, Katrine [1 ,2 ,3 ,4 ]
Gude, Einar [1 ,3 ,4 ]
Andreassen, Arne K. [1 ,3 ,4 ]
Gullestad, Lars [1 ,2 ,3 ,4 ]
Broch, Kaspar [1 ,3 ,4 ]
机构
[1] Oslo Univ Hosp, Rikshosp, Dept Cardiol, Sognsvannsveien 20, N-0372 Oslo, Norway
[2] Univ Oslo, Oslo, Norway
[3] Univ Oslo, Fac Med, KG Jebsen Cardiac Res Ctr, Oslo, Norway
[4] Univ Oslo, Ctr Heart Failure Res, Fac Med, Oslo, Norway
关键词
cardiac transplant; heart transplant; iron deficiency; peak oxygen consumption; health-related quality of life; CHRONIC HEART-FAILURE; FERRIC CARBOXYMALTOSE; EXERCISE CAPACITY; MONOFER(R); REJECTION;
D O I
10.1016/j.healun.2021.01.1390
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 mg/liter or 100 to 300 mg/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 mg/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 mu g/liter or 100 to 300 mu g/liter in combination with transferrin saturation <20%. (C) 2021 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.
引用
收藏
页码:359 / 367
页数:9
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