Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients (IronIC)
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|ClinicalTrials.gov Identifier: NCT03662789|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant Recipients||Drug: Iron Isomaltoside 1000 Other: Placebo: NaCl 0,9%||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, placebo controlled, parallel group, double blind design|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Opaque envelopes, infusion administered by third party, concealed infusion|
|Official Title:||Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients|
|Actual Study Start Date :||April 25, 2018|
|Estimated Primary Completion Date :||April 14, 2019|
|Estimated Study Completion Date :||October 15, 2019|
Active Comparator: Iron isomaltoside 1000
The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment).
Drug: Iron Isomaltoside 1000
Other Name: Monofer B03AC-
Placebo Comparator: Placebo
Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%
Other: Placebo: NaCl 0,9%
- Peak oxygen consumption [ Time Frame: 6 months after intervention ]The primary endpoint will be the baseline-adjusted between-group difference in peak oxygen consumption as measured on a treadmill exercise test
- Iron deficiency [ Time Frame: 6 months after intervention ]The number of patients with absolute or functional iron deficiency
- Muscle strength [ Time Frame: 6 months after intervention ]Baseline-adjusted muscle strength as measured by a hand-grip dynamometer
- Body composition [ Time Frame: 6 months after intervention ]Body composition measured with the InBody 770 Body Composition Analyzer
- Cognitive function [ Time Frame: 6 months after intervention ]Baseline-adjusted cognitive function as assessed by the Cambridge Neuropsychological Test Automated Battery
- Health related quality of life: SF-36 [ Time Frame: 6 months after intervention ]Baseline-adjusted quality of life as assessed with the 36-item short form survey (SF-36), where eight healt consepts are scored by numbers; physical function (1-3), bodily pain (1-5), role limitations due to physical healthproblems (1-5), role limitations due to personal or emotional problems (1-5), emotional well-being (1-5), social function (1-5), energy/fatigue (1-5), and general health perseptions (1-5).
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: 6 months after intervention ]The between-group difference in baseline-adjusted NT-proBNP
- C-reactive protein (CRP) [ Time Frame: 6 months after intervention ]The between-group difference in baseline-adjusted CRP
- Cardiac troponin T (TnT) [ Time Frame: 6 months after intervention ]The between-group difference in baseline-adjusted TnT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662789
|Contact: Lars Gullestad, MD, PhD||0047 firstname.lastname@example.org|
|Contact: Kaspar Broch, MD, PhD||0047 email@example.com|
|Oslo university Hospital, Rikshospitalet||Recruiting|
|Oslo, Norway, 0372|
|Contact: Lars Gullestad, MD, PhD 0047 23070000 firstname.lastname@example.org|
|Contact: Kaspar Broch, MD, PhD 0047 92091824 email@example.com|
|Principal Investigator:||Lars Gullestad, MD, PhD||Oslo University Hospital|