Home › Univentricular Heart › NCT07220226
Venous Compression in Fontan
Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.
Who can join
Ages 18 to 45 · All sexes · Healthy volunteers welcome
Full eligibility 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.
About the study
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:
1. Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation. 2. 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.
What is being tested
- Lower extremity compression garments (device)
- Without compression garments (other)
Sponsor: University of Texas Southwestern Medical Center · Participants: 20 · Started: May 10, 2026
Contact the study team
- Keri Shafer, MD · Phone: 2146451165
- Denis J Wakeham, PhD · Phone: 2146451165
Official record on ClinicalTrials.gov — NCT07220226
Locations in the U.S.
| Texas | UT Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.