Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients (IronIC): Rationale and Design of a Randomized, Controlled Trial

JOURNAL OF HEART AND LUNG TRANSPLANTATION(2019)

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摘要
Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %. The IronIC trial (NCT03662789) is designed to test the hypothesis that intravenous (i.v.) iron therapy will improve peak oxygen consumption, muscle strength, cognitive capacity and quality of life in these patients. Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin < 100 g/ l, red blood cell disorders, end-stage kidney failure, intolerance to iron isomaltoside, and ongoing infections or rejections. Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of iron in heart transplant recipients with ID. We expect results to be available at the end of 2019. Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %. The IronIC trial (NCT03662789) is designed to test the hypothesis that intravenous (i.v.) iron therapy will improve peak oxygen consumption, muscle strength, cognitive capacity and quality of life in these patients. The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin < 100 g/ l, red blood cell disorders, end-stage kidney failure, intolerance to iron isomaltoside, and ongoing infections or rejections. All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
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关键词
iron deficiency,cardiac transplant recipients,supplement
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