An interventional study of Intravenous administration of ferric carboxymaltose and Subacute hypoxic exposures in Lung Hypoxia, Pulmonary Arterial Hypertension and Iron Deficiency, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-06.
Sponsored by University of Oxford · Not applicable, Interventional, and Basic science
On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise and that lowering iron by giving a drug that binds iron, magnifies this response. This is potentially a clinically important observation since iron-deficient people may be at increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due to lung disease or residence at high altitude; furthermore if this were true then intravenous iron could be an important treatment in this patient group in the event of hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor' or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood pressure through the lungs.
This study will answer the question (1) do iron-deficient volunteers have a greater rise in PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete? The purpose of this study is not to test the safety or clinical efficacy of iron which is already known.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 31 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
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Exclusion Criteria:
Healthy volunteers meeting iron-deficient entry criteria; Intravenous administration of ferric carboxymaltose; Subacute hypoxic exposures
Drug: Intravenous administration of ferric carboxymaltose · Other: Subacute hypoxic exposures
Healthy volunteers meeting iron-replete entry criteria; Intravenous administration of ferric carboxymaltose; Subacute hypoxic exposures
Drug: Intravenous administration of ferric carboxymaltose · Other: Subacute hypoxic exposures
Intravenous administration of ferric carboxymaltose 15mg/kg up to a maximum dose of 1000mg
Also known as: Ferinject
Exposure to six hours of isocapnic hypoxia with end-tidal partial pressure of oxygen clamped at 55 Torr, with and without prior iron infusion
Also known as: Hypoxia, Hypoxic challenge
∆PASP in iron-replete compared to iron-deficient volunteers
Difference between the rise in pulmonary artery systolic pressure during a hypoxic challenge in iron-replete compared to iron-deficient volunteers
Time frame: During six hours of hypoxia without prior iron infusion
∆PASP, with versus without prior iron infusion, in iron-replete compared to iron-deficient volunteers
Difference between the rise in pulmonary artery systolic pressure during a hypoxic challenge in iron-replete compared to iron-deficient volunteers, with versus without a prior iron infusion
Time frame: During two six-hour periods of hypoxia; assessments separated by at least a week
Blood parameter changes, pre- versus post-intravenous iron, in iron-replete compared to iron-deficient volunteers
Time frame: After six hours of hypoxia, at both study assessments
Ventilation parameter changes, pre- versus post-intravenous iron, in iron-replete compared to iron-deficient volunteers
Time frame: During six hours of hypoxia, at both study assessments
Fatigue scores in iron-replete versus iron-deficient volunteers
Time frame: Assessed at baseline visit
Plan to share: No
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
University of Oxford