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NCT Number: NCT07220226

Venous Compression in Fontan

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

214-345-4670

Keval Patel, M.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lower extremity compression garments

Device

Acute and 2-week effects of compression garments

Without compression garments

Other

Acute effects without compression garments

Primary outcomes

  1. 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

  2. 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 without compression garments during baseline testing

  3. 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.

  4. 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

  5. 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.

Secondary outcomes

  1. Change in Venous Return with Exercise

    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

  2. Change in Venous Return with Exercise

    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

  3. Change in Venous Return with Exercise

    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

  4. The Acute Effect of Compression Garments on Changes in Venous Return with Exercise

    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

  5. The Chronic Effect of Compression Garments on Changes in Venous Return with Exercise

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denis J Wakeham, PhD

CONTACT

[email protected]

2146451165

Keri Shafer, MD

CONTACT

[email protected]

2146451165

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2025
Registry last updated
Jul 30, 2026

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.

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