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Venous Compression in Fontan

RecruitingNAAges 18 Years - 45 YearsAllUniversity of Texas Southwestern Medical Center
NCT07220226 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 hour

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📋 Eligibility rules (as published)
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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What it tests

  • Lower extremity compression garments
  • Without compression garments
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Where

1 site
UT Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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