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Venous Compression in Fontan

NCT07220226 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-22

No results posted yet for this study

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:

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.

Conditions

  • Single-ventricle
  • Fontan Circulation

Interventions

DEVICE

Lower extremity compression garments

Acute and 2-week effects of compression garments

OTHER

Without compression garments

Acute effects without compression garments

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Keri Shafer, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220226 on ClinicalTrials.gov