About this trial
Before birth, the foramen ovale is a normal opening in the heart that allows blood to flow from the mother to the baby. After birth, this opening usually closes. However, in up to 38% of the population it does not fully close and is then called a patent foramen ovale (PFO). Having a PFO allows venous (blue) blood to mix with arterial (red) blood in the heart, which can lower blood oxygen levels. The mixing of blood has been suggested to be greater during exercise and with exposure to high-altitude. Also, people with a PFO may be a greater risk for severe altitude sickness, specifically involving the collection of fluid in the lungs which makes breathing very difficult - this is called high-altitude pulmonary edema (HAPE).
No study has directly measured the pressure difference across the heart which is required for the mixing of blood during exercise or at high-altitude. The present study will directly measure the pressure difference across the heart, as well as blood flow through the PFO during rest and exercise in simulated high altitude in adults with and without a PFO and a previous history of severe altitude sickness. The study will test the hypothesis that elevations in pulmonary artery pressure during exposure to hypoxia will not elicit a pressure gradient, and thus blood flow, across the PFO neither at rest nor during exercise.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females age > 18 but < 60 years of age at the time of signing the informed consent.
Medically documented episode of noncardiogenic pulmonary edema occurring after exposure to hypoxia at high altitude.
No other associated congenital cardiac or vascular abnormalities.
Physically active, and able to perform endurance exercise.
Disqualifiers
Do not otherwise meet the inclusion criteria.
Cardiac- or pulmonary-related medications.
Known history of anemia, iron deficiency, iron supplementation (oral or intravenous) in the preceding 60 days.
Systemic anticoagulation or aspirin use that cannot be temporarily held for the study.
Trial population
Individuals with documented history of high-altitude pulmonary edema and with or without a patent foramen ovale
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Transmural pressure
Absolute difference between pulmonary capillary wedge pressure and right atrial pressure
Arterial oxygen saturation
Pulse oxygen saturation
Secondary outcomes
Gas exchange
Oxygen uptake and carbon dioxide production
Arterio-venous oxygen different
Cardiac output
Right ventricular diameter
Locations
Sponsors and contacts
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