Compression Garments for Single Ventricle Heart
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Keri Shafer, MD
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-45 who have had a Fontan procedure due to single ventricle heart conditions. Participants must be patients at UT Southwestern and have a Fontan circulation.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lower extremity compression garments
Trial Overview
The study tests whether wearing lower body compression garments can improve heart function during exercise in people with Fontan circulation, compared to not wearing the garments. Some participants will also wear the garments daily for two weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Healthy group participants will undergo Rest +Submax exercise with and without wearing venous compression garments.
Fontan circulation participants will undergo Rest +Submax exercise with and without wearing venous compression garments. A subset of patients with Fontan circulation will undergo repeat testing 2-weeks later.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
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