Transplant Trial Watch

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

Brautaset Englund, K. V., et al.

Journal of Heart & Lung Transplantation 2021 [record in progress].


Aims
This study aimed to investigate whether intravenous iron therapy led to improvement in peak oxygen consumption in cardiac transplant patients.

Interventions
Participants were randomly assigned to either the intravenous ferric derisomaltose group or the placebo group.

Participants
52 heart transplant patients.

Outcomes
The primary endpoint was peak oxygen consumption. The secondary outcomes included iron deficiency (absolute or functional), muscle strength, quality of life, cardiac function and safety.

Follow-up
6 months

CET Conclusions
The double-blind, randomised controlled trial tested the hypothesis that a single intravenous infusion of ferric derisomaltose would improve peak oxygen consumption in heart transplant recipients with iron deficiency who were at least one year posttransplant. Patients were randomised according to a computer-generated randomisation list and allocation was concealed by using opaque, sealed envelopes. Double-blinding was ensured by using the following procedure: a nurse not otherwise involved in the study prepared and administered the infusion solution, the patient was blindfolded, and the injection site, syringes, and intravenous lines were all covered. The sample size calculation was based on the primary outcome peak oxygen consumption and indicated that 102 patients would provide 80% power, taking into account dropouts. Peak oxygen consumption did not differ at the 6-month follow-up. The change in health-related quality of life was greater in the intervention arm (EQ-5D-3L) compared to placebo, however this was not the case for the physical component of the SF-36. A pre-specified subgroup analysis showed that patients with very low iron at baseline (ferritin <30 mg/liter, n=12) did show an improvement in peak oxygen consumption.

Jadad score
5

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT03662789

Funding source
Industry funded