Venous Compression for Fontan Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates if external venous compression improves exercise stroke volume in adults with Fontan circulation. Participants undergo MRI- and exercise-based testing with and without compression garments, including a 2-week wear period for a subset. The protocol includes detailed cardiovascular assessments at rest and during submaximal exercise, with measurements such as blood pressure, oxygen uptake, and cardiac output. Eligibility focuses on adults 18–45 with Fontan physiology, excluding those with advanced disease or high-risk conditions. The lead site is UT Southwestern, Dallas, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Keri Shafer, MD — University of Texas Southwestern Medical Center
• Study coordinator: Keri Shafer, MD
• Email: keri.shafer@utsouthwestern.edu
• Phone: 2146451165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.