Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients
Condition: Heart Transplant Recipients
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Iron deficiency is prevalent in heart transplant recipients, and may be associated with
      reduced functional capacity. The IronIC trial is designed to assess the effect of intravenous
      iron isomaltoside on exercise capacity, muscle strength, cognition and quality of life in
      iron-deficient heart transplant recipients
    

Detailed description: 
      Iron deficiency is prevalent in patients with heart failure. Iron deficiency is associated
      with a worse prognosis, and randomised controlled trials have shown that correction of iron
      deficiency with intravenous iron therapy improves functional capacity, quality of life, and
      6-minute walk distance. Current guidelines therefore recommend intravenous iron substitution
      in patients with heart failure with reduced ejection fraction and iron deficiency.
      Intravenous iron is more effective, better tolerated, and improves quality of life to a
      greater extent than oral iron supplements. In the IRONOUT HF trial, in which 225 patients
      with systolic heart failure were randomised to oral iron supplement or placebo, there was no
      effect on oxygen uptake, 6-minute walk distance, or quality of life. The authors attributed
      the negative results to the minimal effect on iron stores, suggesting that oral iron does not
      adequately replenish iron stores in patients with heart failure.

      Cardiac allograft recipients resemble patients with heart failure in many respects. Prior to
      transplantation, and in some instances after heart transplantation, they have had overt heart
      failure. Moreover, due to the immunologic challenge posed by the allograft, and their
      susceptibility to infection due to immunosuppressive treatment, cardiac allograft recipients
      have low-grade inflammation. This low-grade inflammation makes it difficult to interpret iron
      stores, and results in dysregulated iron metabolism.

      There have been no studies to assess the effect of intravenous iron therapy in heart
      transplant recipients who have iron deficiency. There is reason to believe that a liberal
      definition of iron deficiency should be used in cardiac allograft recipients, and the
      investigators have elected to use the well-established definition used in patients with heart
      failure: serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a
      transferrin saturation < 20 %. Because oral iron supplement is less effective then
      intravenous iron in general, and in patients with heart failure in particular, the
      investigators assume that oral iron supplement is inadequate in heart transplant recipients.
      the investigators have designed the IronIC trial to assess the effect of intravenous iron
      isomaltoside on exercise capacity, muscle strength, cognition and quality of life in
      iron-deficient heart transplant recipients.
    

Intervention name(s): Iron Isomaltoside 1000; Placebo: NaCl 0,9%
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion; Intravenous infusion
Other intervention name(s): Monofer B03AC-
Intervention MeSH terms: Iron isomaltoside 1000
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled, parallel group, double blind design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart transplant; Iron deficiency; Intravenous iron supplement; Peak oxygen consumption; Cardiopulmonary exercise test; Cognitive function; Muscle strength