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Simple leg sleeves may boost heart function during exercise in fontan patients

NCT ID NCT07220226

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 20 people

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

Started

May 2026

Expected to finish

Nov 2027

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.

Ages

18 to 45 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.

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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