Venous Compression in Fontan (NCT07220226)
Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (13 items).
Location: UT Southwestern Medical Center — Dallas, Texas
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UT Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 645-1165
Email: keri.shafer@utsouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.