Venous Compression in Fontan

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07220226
Status
Recruiting
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Conditions

  • Fontan Circulation
  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Lower extremity compression garments — DEVICE
    Acute and 2-week effects of compression garments
  • Without compression garments — OTHER
    Acute effects without compression garments

Study Details

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.

Key Dates

First listed
Oct 23, 2025
Start date
May 10, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Experimental: Healthy controls
    Healthy group participants will undergo Rest +Submax exercise with and without wearing venous compression garments.

Primary Outcome Measure

Change in Stroke Volume with Exercise [ Time Frame: Rest (20 minutes), Exercise (10 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Keval Patel, M.D.
[email protected]
214-345-4670
Keri Shafer, M.D. (PRINCIPAL_INVESTIGATOR)
Keval Patel, M.D. (SUB_INVESTIGATOR)

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