Pulmonary Hypertension Clinical Trial
Official title:
Physiology Study Investigating the Effects of Supplementation and Depletion of Iron on Hypoxia-related Pulmonary Hypertension
The study hypothesis is that body iron levels are important in determining the increase in lung blood pressure that occurs in response to low oxygen levels. The purpose of this study is to determine whether this is true at high altitude, where oxygen levels are low.
Pulmonary hypertensive disorders frequently complicate hypoxic lung disease and worsen
patient survival. Hypoxia-induced pulmonary hypertension is also a major cause of morbidity
at high altitude. Hypoxia causes pulmonary hypertension through hypoxic pulmonary
vasoconstriction and vascular remodelling. These processes are thought to be regulated at
least in part by the hypoxia-inducible factor (HIF) family of transcription factors, which
coordinate intracellular responses to hypoxia throughout the body.
HIF is regulated through a cellular degradation process that requires iron as an obligate
cofactor. In cultured cells HIF degradation is inhibited by reduction in iron (by chelation
with desferrioxamine) and potentiated by iron supplementation. In humans, we have recently
shown that, in laboratory experiments lasting 8 hours, acute iron supplementation blunts the
pulmonary vascular response to hypoxia, while acute iron chelation with desferrioxamine
enhances the response.
This suggests that iron may also affect the pulmonary artery pressure response to hypoxia
over longer time periods. The purpose of this study is to investigate this link between iron
and the pulmonary artery pressure response to hypoxia, through a study conducted at high
altitude allowing concurrent exposure of larger numbers of participants to environmental
hypoxia. We wish to explore the extent and the time-course of the effect of iron on
pulmonary artery pressure. Cerro de Pascu (4,340 m) in Peru provides the unique ability to
make rapid transitions from sea level to high altitude (6-8 hours by road), together with
the requisite research facilities. Also, one part of this study involves recruitment of
patients with chronic mountain sickness, of whom there are many living in Cerro de Pasco.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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