Simple leg sleeves may boost heart function during exercise in fontan patients
NCT ID NCT07220226
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether wearing compression garments on the legs can increase the amount of blood the heart pumps during exercise in adults with Fontan circulation. Twenty participants will undergo exercise tests with and without the garments, and a subset will wear them for two weeks. The goal is to see if this simple device can improve exercise function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lower extremity compression garments
- What this could lead to
- If it works, compression garments could become a simple, non-drug way to improve exercise capacity and quality of life for people with Fontan circulation.
- What could go wrong
- This is a very small, early-stage study (20 people) testing a short-term effect. It may not show a meaningful benefit, and results may not apply to all Fontan patients.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patients with a Fontan circulation - Inclusion criteria: • Patients at UTSW aged 18-45 years old with a Fontan circulation. Exclusion Criteria: * NYHA Class 4 * Severe AV valve regurgitation * Severe ventricular dysfunction * Large ascites * Significant varicosities * Atrio-pulmonary (AP) Fontan * Known Fontan thrombus * Poorly controlled arrythmia * Unplanned cardiac admission in the last 6 months * Cyanosis (resting O2 saturation \<85%) * Pregnant * Common femoral vein obstruction \>50% to be performed following completion of informed consent. Healthy Controls: Healthy control participants will be recruited on the basis of having no known chronic diseases and not currently taking any cardiovascular medications.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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