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Clinical trialNCT07742540Not, yet, recruitingObservational

The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia

SponsorUniversity of Texas Southwestern Medical CenterEnrollment50High Altitude Pulmonary EdemaPatent Foramen Ovale (PFO)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Benjamin D. Levine, M.D.

    The University of Texas Southwestern Medical Center Dallas

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Sept 2026
Primary completion
31 Dec 2027
Completion
15 Sept 2028
Last update posted
3 Aug 2026
Registered enrollment
50
Registry id
NCT07742540

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.