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Dopamine may unclog lymphatic system in rare heart complication

NCT ID NCT03322345

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study looks at whether dopamine can improve lymph flow in people who developed protein-losing enteropathy (PLE) after Fontan surgery for single-ventricle heart disease. PLE is a serious complication where proteins leak into the gut, possibly due to poor lymphatic function. Researchers will track markers of lymph circulation and PLE symptoms in a small group of patients receiving dopamine along with standard treatments during flare-ups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dopamine
What this could lead to
If successful, this could clarify whether dopamine improves lymphatic function in Fontan-associated protein-losing enteropathy, potentially pointing toward a new treatment approach.
What could go wrong
This is a very small observational study (only 3 participants) with no control group, so results may not be generalizable. It is exploratory and may not lead to a proven therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

3 people

The number who actually took part.

Started

Apr 2019

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will be prospective cohort of patients who have undergone Fontan surgery and are currenty followed within the University of Michigan Congenital Heart Center. The target populations are patients with protein losing enteropathy (PLE) that are having increased disease symptoms requiring additional treatment. Those that have PLE refractory to other treatments and require the addition of continuous dopamine infusion to their treatment regimen will be recruited to the dopamine group. Those that have PLE worsening that require the addition of other treatments except the initiation of continuous dopamine infusion will be recruited to the control group.

Ages

3 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

congenital heart disease protein-losing enteropathy univentricular heart

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Catecholamine Congenital heart disease Dopamine LYMPH Lymphatic system Protein-losing enteropathies Single-ventricle

Contacts and locations

Locations

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

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