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

Stopped early

Conditions studied: Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph, Catecholamine, Single-ventricle, Congenital Heart Disease

In brief

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 facts

Study ID

NCT03322345

Run by

University of Michigan

People needed

3

Starts

2019-04-09

Expected to finish

2026-05-14

Last updated by the study team

2026-07-14

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females with Fontan physiology of any age
• Must have protein losing enteropathy with current worsening who require additional therapies
• Participant consent or parental/guardian consent and participant assent

You may not qualify if…

• Patients with inflammatory bowel disease (i.e Crohn's, ulcerative colitis)
• Patients with systemic autoimmune disease (i.e. Systemic Lupus Erythematous)
• Patients with primary immunodeficiency syndromes
• Patients with nephrotic syndrome
• Patients with anemia
• Patients less than 31 pounds

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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