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Venous Compression in Fontan

University of Texas Southwestern Medical Center · NCT07220226

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
May 10, 2026
Record last updated
July 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses:

  • Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation.
  • Patients with significant venous varicosities will have a greater response to venous compression.

Participants will

  • Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments
  • Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments
  • A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.

Participants will

  • Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments
  • Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments
  • A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.

Being studied: Lower extremity compression garments; Without compression garments

Conditions: Single-ventricle; Fontan Circulation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • UT Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Keval Patel, M.D. · 214-345-4670 · keval.patel@utsouthwestern.edu

Study contacts (from the official record)

  • Keri Shafer, MD · 2146451165 · keri.shafer@utsouthwestern.edu
  • Denis J Wakeham, PhD · 2146451165 · denis.wakeham@utsouthwestern.edu
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Venous Compression in Fontan (NCT07220226) | Bored Studies