Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT03322345
Status
Enrolling By Invitation

Conditions

  • Catecholamine
  • Congenital Heart Disease
  • Dopamine
  • Lymph
  • Lymphatic System
  • Protein-Losing Enteropathies
  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE). Some studies suggest PLE is primarily caused by impaired lymph flow. Use of continuous dopamine infusion can improve PLE. Evidence suggests the effect of dopamine may be through its effect on lymphatic function. This observational study looks at markers of lymph flow and PLE symptoms after treatment using dopamine and other standard therapies during disease exacerbations.

Key Dates

Start date
Apr 9, 2019
Status verified
Mar 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
24 participants (estimated)

Arms

  • Arm: Dopamine Added
    Patients with protein losing enteropathy (PLE) that have an exacerbation such that their treating physicians decide to add continuous dopamine infusion to their current therapies.
  • Arm: No dopamine added (control)
    Patients with protein losing enteropathy (PLE) that have an exacerbation such that their treating physicians decide to add new therapies to their current therapies but that do not require the addition of continuous dopamine infusion.

Primary Outcome Measure

Change in CD4 counts [ Time Frame: Baseline to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Health SystemAnn ArborMichigan48109-

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