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Could a tiny heart hole worsen altitude sickness?

NCT ID NCT07742540

Knowledge-focused Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at how a small opening in the heart, called a patent foramen ovale (PFO), affects blood flow and oxygen levels during exercise and simulated high altitude. About a third of people have this opening, which may allow oxygen-poor blood to mix with oxygen-rich blood, potentially increasing the risk of high-altitude pulmonary edema (HAPE), a dangerous fluid buildup in the lungs. Researchers will measure pressures inside the heart and blood flow through the PFO in adults with and without a history of HAPE. The goal is to understand whether this heart opening contributes to altitude sickness, which could help identify at-risk individuals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No drug or device is being tested. The study measures heart pressures and blood flow during rest and exercise in simulated high altitude.
What this could lead to
If the study clarifies how a PFO affects heart function at high altitude, it could help identify who is at risk for severe altitude sickness and guide prevention strategies.
What could go wrong
This is a small observational study, so findings may not apply to everyone. It does not test a treatment, so it won't directly change care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with documented history of high-altitude pulmonary edema and with or without a patent foramen ovale

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

altitude sickness high altitude pulmonary edema Hypoxia Motor Activity patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-altitude pulmonary edema Patent foramen ovale (PFO)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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