The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: HAPE+PFO
Group B: HAPE

Trial outcomes

Primary outcomes

1

Transmural pressure

Absolute difference between pulmonary capillary wedge pressure and right atrial pressure

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
2

Arterial oxygen saturation

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
3

Pulse oxygen saturation

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.

Secondary outcomes

1

Gas exchange

Oxygen uptake and carbon dioxide production

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
2

Arterio-venous oxygen different

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
3

Cardiac output

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.
4

Right ventricular diameter

Time frame
During 5 minutes of rest in normoxia, after 15 minutes of exercise in normoxia, after 90 minutes of rest in hypoxia, after 15 minutes of exercise in hypoxia.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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