Venous Compression in Fontan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Texas Southwestern Medical Center
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
NYHA Class 4
Severe AV valve regurgitation
Severe ventricular dysfunction
Large ascites
Trial design
Design model
Sequential
Treatments tested in this trial
Lower extremity compression garments
DeviceAcute and 2-week effects of compression garments
Without compression garments
Other interventionAcute effects without compression garments
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Fontan circulation ArmExperimental treatment 2 interventions
Group B: Healthy controlsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Stroke Volume with Exercise
The change in single ventricular stroke volume from rest to moderate intensity exercise with compression garments during baseline testing
Time frame
Rest (20 minutes), Exercise (10 minutes)2
Change in Stroke Volume with Exercise
The change in single ventricular stroke volume from rest to moderate intensity exercise without compression garments during baseline testing
Time frame
Rest (20 minutes), Exercise (10 minutes)3
Change in Stroke Volume with Exercise
The change in single ventricular stroke volume from rest to moderate intensity exercise following 2 weeks of wearing compression garments.
Time frame
Rest (20 minutes), Exercise (10 minutes) at 2-weeks follow-up testing4
The Acute Effect of Compression Garments on Stroke Volume during Exercise
The difference in the change in single ventricular stroke volume during moderate intensity exercise between baseline testing with (outcome #1) and without (outcome #2) garments
Time frame
Rest (20 minutes) and Exercise (10 minutes) repeated during baseline testingSecondary outcomes
1
Change in Venous Return with Exercise
The change in inferior vena cava flow from rest to moderate intensity exercise with compression garments using MRI during baseline testing
Time frame
Rest (10 minutes) and Exercise (5 minutes)2
Change in Venous Return with Exercise
The change in inferior vena cava flow from rest to moderate intensity exercise without compression garments using MRI during baseline testing
Time frame
Rest (10 minutes) and Exercise (5 minutes)3
Change in Venous Return with Exercise
The change in inferior vena cava flow from rest to moderate intensity exercise following 2 weeks of wearing compression garments using MRI
Time frame
Rest (10 minutes) and Exercise (5 minutes)4
The Acute Effect of Compression Garments on Changes in Venous Return with Exercise
The difference in the change in inferior vena cava flow during moderate intensity exercise between baseline testing with (outcome #6) and without (outcome #7) garments
Time frame
Rest (10 minutes) and Exercise (5 minutes) repeated during baseline testingSponsors and contacts
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Source ClinicalTrials.gov