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During alveolar hypoxia, for example at high altitude or in patients with respiratory disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit exercise performance. Intravenous iron supplementation has recently been shown to reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized that intravenous iron supplementation would enhance exercise capacity during alveolar hypoxia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous iron sucrose | Experimental | Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline. |
|
| Intravenous normal saline | Placebo Comparator | Infusion of 100 ml normal (0.9%) saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose. | Drug | Volunteers will receive an intravenous infusion of 200 mg iron sucrose, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption. | Volunteers will receive either intravenous iron or saline placebo, before exposure to 8 hours of alveolar hypoxia. They will then undergo an exercise test while breathing an hypoxic gas mixture. The primary outcome measure will be exercise capacity as determined by maximal oxygen consumption during this test. Volunteers will receive both interventions, via a crossover design. Due to uncertainty about the duration of action of iron at a cellular level, all volunteers will receive saline infusion on the first study day, and iron sucrose infusion on a second study day, at least one week later. | After 8-h exposure to alveolar hypoxia. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal exercise capacity, assessed by peak power output. | After 8-h exposure to alveolar hypoxia. | |
| Pulmonary artery systolic pressure. | After 8-h exposure to alveolar hypoxia. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick P Talbot, DPhil MRCP | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physiology, Anatomy & Genetics, University of Oxford | Oxford | OX1 3PT | United Kingdom |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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|
|
| Normal saline | Drug | Volunteers will receive an intravenous infusion of 100 ml normal saline, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas. |
|
| Blood levels of oxygen-regulated proteins. |
| After 8-h exposure to alveolar hypoxia |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |