Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Stroke Volume with Exercise
Study Overview
Brief Summary
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:
- Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation.
- 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.
Detailed Description
Study Day 1 - Consent, Screening and Garment Measurements:
Following assessment of participant eligibility, all participants will undergo leg venous ultrasound assessment and abdominal-foot measurements for the custom making of compression garments.
Study Day 2 - MRI:
Study participants will undergo comprehensive cardiovascular MRI using a 3T MRI scanner with and without compression garments and exercise.
Study Day 3 - Cardiovascular & Exercise Testing Day:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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%)
- •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.
Arms & Interventions
Healthy controls
Healthy group participants will undergo Rest +Submax exercise with and without wearing venous compression garments.
Intervention: Lower extremity compression garments (Device)
Healthy controls
Healthy group participants will undergo Rest +Submax exercise with and without wearing venous compression garments.
Intervention: Without compression garments (Other)
Fontan circulation Arm
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.
Intervention: Lower extremity compression garments (Device)
Fontan circulation Arm
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.
Intervention: Without compression garments (Other)
Outcomes
Primary Outcomes
Change in Stroke Volume with Exercise
Time Frame: Rest (20 minutes), Exercise (10 minutes) at 2-weeks follow-up testing
The change in single ventricular stroke volume from rest to moderate intensity exercise following 2 weeks of wearing compression garments.
The Acute Effect of Compression Garments on Stroke Volume during Exercise
Time Frame: Rest (20 minutes) and Exercise (10 minutes) repeated during baseline testing
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
The Chronic Effect of Compression Garments on Stroke Volume during exercise
Time Frame: Rest (20 minutes) and Exercise (10 minutes) completed during baseline and during follow-up testing
The difference in the change in single ventricular stroke volume during moderate intensity exercise between baseline testing without garments (outcome #2) and following 2 weeks of wearing compression garments (outcome #3) in patients with Fontan Circulation.
Change in Stroke Volume with Exercise
Time Frame: Rest (20 minutes), Exercise (10 minutes)
The change in single ventricular stroke volume from rest to moderate intensity exercise with compression garments during baseline testing
Secondary Outcomes
- The Acute Effect of Compression Garments on Changes in Venous Return with Exercise(Rest (10 minutes) and Exercise (5 minutes) repeated during baseline testing)
- The Chronic Effect of Compression Garments on Changes in Venous Return with Exercise(Rest (10 minutes) and Exercise (5 minutes) completed during baseline and during follow-up testing)
- Change in Venous Return with Exercise(Rest (10 minutes) and Exercise (5 minutes))
Investigators
Keri Shafer
Associate Professor of Medicine
University of Texas Southwestern Medical Center