UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
Location contact
Keri Shafer, M.D.
PRINCIPAL_INVESTIGATOR
Keval Patel, M.D.
CONTACT
Keval Patel, M.D.
SUB_INVESTIGATOR
NCT Number: NCT07220226
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
Keri Shafer, M.D.
PRINCIPAL_INVESTIGATOR
Keval Patel, M.D.
CONTACT
Keval Patel, M.D.
SUB_INVESTIGATOR
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:
All participants will undergo comprehensive cardiovascular structure and function assessments at rest and during exercise with and without the wearing of compression garments. Baseline testing will include dual x-ray absorptiometry (DEXA), pulmonary function testing, comprensive vascular assessments and echocardiography. During exercise at two submaximal workloads, the study team will measure blood pressure, oxygen uptake and cardiac output.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Patients with a Fontan circulation -
Inclusion criteria
Exclusion criteria
Healthy Controls:
Healthy control participants will be recruited on the basis of having no known chronic diseases and not currently taking any cardiovascular medications.
Acute and 2-week effects of compression garments
Acute effects without compression garments
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
Time frame: Rest (20 minutes), Exercise (10 minutes)
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) 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.
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
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.
Time frame: Rest (10 minutes) and Exercise (5 minutes)
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)
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)
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) repeated during baseline testing
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) completed during baseline and during follow-up testing
The difference in the change in inferior vena cava flow during moderate intensity exercise between baseline testing without garments (outcome #7) and following 2 weeks of wearing compression garments (outcome #8) in patients with Fontan Circulation.
Contact information is provided by the study sponsor or research team.
Denis J Wakeham, PhD
CONTACT
Keri Shafer, MD
CONTACT
University of Texas Southwestern Medical Center
Other
Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07087782
Cardiovascular Abnormalities, Cardiovascular Diseases
Corpus Christi, Texas, United States
View Trial DetailsNCT06918795
Cardiovascular Abnormalities, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06434207
Cardiovascular Abnormalities, Cardiovascular Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT06613477
Cardiovascular Abnormalities, Cardiovascular Diseases
Durham, North Carolina, United States
View Trial Details