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

Abstract

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 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 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.