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NCT Number: NCT07742540

The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Non-cardiopulmonary disorders that adversely influence exercise ability (e.g. arthritis or peripheral vascular disease).
  • Engaging in vigorous physical activity [≥1 hour at ≥6 mets] at ≥8,000 ft for >2 days per week over the preceding 4 weeks, and residing at ≥8,000 ft for 3 or more consecutive nights in the preceding 30 days.
  • History of any recent illnesses (e.g. viral respiratory infections) within 4 weeks of testing.
  • Women who are pregnant (urine pregnancy test given to all women of childbearing age at the time of testing).
  • Other conditions that would limit the patient's ability to complete the study procedures.

Treatment and study plan

Primary outcomes

  1. Transmural 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.

    Absolute difference between pulmonary capillary wedge pressure and right atrial pressure

  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

    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.

    Oxygen uptake and carbon dioxide production

  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.

  5. Tricuspid regurgitant jet velocity

    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.

  6. Tricuspid annular plane systolic excursion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giorgio Manferdelli, Ph.D.

CONTACT

[email protected]

214-345-7134

Mary Childers

CONTACT

[email protected]

214-345-6459

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

The Role of Patent Foramen Ovale on Cardiac Hemodynamics and Exercise Cardiac Reserve in HAPE-susceptible Individuals

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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