An observational study in Dopamine, Protein-Losing Enteropathies and Lymphatic System, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University of Michigan · Observational
Among 55 studies in Univentricular Heart with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Univentricular Heart · United States.
Among the 55 studies in Univentricular Heart with a site in United States, this one is the 22nd largest by enrollment of the 23 observational ones that give a count, is one of 4 that started in 2019, is one of 23 observational ones, and was the 28th registered.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
Browse Univentricular Heart studies →13 of the 55 studies in Univentricular Heart with a site in United States are open now. Recruiting first, the newest first:
Le Bonheur Children's Hospital · Sites in United States
Ages 0 mo–12 mo
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–45 · Healthy volunteers
Children's Hospital Los Angeles · Sites in United States
Ages 12–21
Driscoll Children's Hospital · Sites in United States
Ages 0 mo–6 mo
Children's Hospital of Philadelphia · Sites in United States
Ages 10–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Univentricular Heart studies recruiting now, 8 (38%) set no upper age limit and 13 (62%) stop at 75 or younger; 16 take children under 18; 1 takes healthy volunteers.
This study: 3 Years and older · all sexes · no healthy volunteers.
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55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 2
First in 2000; this study’s year is marked. 4 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 42 across 37 observational studies indexed under Univentricular Heart.
Median enrollment 24 across the 32 interventional studies, 30 across the 23 observational. Of the 36 that completed or were terminated, 12 (33%) have results posted.
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2 of 55 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 3 studies filed under Univentricular Heart — fewer than ten, so there is no comparison to draw.
5 of the studies in Univentricular Heart with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT06150950Stanford UniversityREHAB Fontan Failure: A Trial of Cardiac Rehabilitation | 2026-12-31 |
| NCT05262907Duke UniversityVentripoint Single Ventricle Study | 2027-08 |
| NCT05647213HeartWorks, Inc.Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease | 2027-09 |
| NCT07220226University of Texas Southwestern Medical CenterVenous Compression in Fontan | 2027-11-01 |
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Among the 55 studies in Univentricular Heart with a site in United States, from their registry updates:
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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.
For infants and newborns who have a heart defect at birth that leaves them with one functional ventricle, there is a series of surgeries that are required to allow survival. These surgeries ultimately lead to a common heart and great blood vessel circulation called a cavopulmonary anastomosis (Fontan). This has allowed for survival into adulthood from universally fatal outcome in infancy. However, the non-physiologic blood flow patterns of the Fontan pathway do result in certain complications, including protein losing enteropathy (PLE), which occurs in 3.7-13.4% of patients. PLE is denoted by the loss of protein, fats, and other key nutrients into the intestines, which can lead to significant morbidity. Recent evidence suggests that this is in part mediated by impaired flow of lymph from the intestines, which is carried by the parallel vascular system called the lymphatic system. Lymphatics return these nutrients and the fluid that leaks out of the blood vessels throughout the body back into the blood circulatory system by functioning as a series of pumps with one-way valves. While few treatments exist from PLE, evidence demonstrates continuous infusion of dopamine can help resolve PLE symptoms. Studies of isolated lymphatic vessels demonstrate that dopamine may increase the ability of lymphatic vessels to pump harder. This suggests the mechanism of action of dopamine in PLE is increasing the return of lymph in the non-physiologic blood flow patterns of Fontan patients. However, the link between improved return of lymph and improvement in PLE has not been established. Therefore, the investigators have designed this study to test whether markers of lymphatic flow and heart pump function improve when patients start continuous dopamine therapy (a standard practice at the University of Michigan for PLE). This involves tracking markers of lymphatic recirculation through serial testing of blood and monitoring of PLE symptoms before and after the start of dopamine and other standard of care therapies. From these data, the investigators will correlate the monitored changes in lymph recirculation with changes in PLE symptoms.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Change in CD4 counts
The change in the number of circulating CD4 lymphocytes will be tracked at multiple time points from baseline to 6 months after start of additional treatment (dopamine and control)
Time frame: Baseline to 6 months
Change in fatty acid profile
The change in the relative ratios of free fatty acids absorption into the the plasma will be tracked at multiple time points from baseline to 6 months after start of additional treatment (dopamine and control)
Time frame: Baseline to 6 months
Change in vitamin D3
The change in the levels of vitamin D3 absorbed and circulating in the plasma will be tracked at multiple time points from baseline to 6 months after start of additional treatment (dopamine and control)
Time frame: Baseline to 6 months
Change in albumin infusion requirements
The change in the number of albumin infusions per month will be tracked each month from baseline to 6 months after start of additional treatment (dopamine and control)
Time frame: Baseline to 6 months
Change in IVIG infusion requirements
The change in the number of IVIG infusions per month will be tracked each mother from baseline to 6 months after start of additional treatment (dopamine and control)
Time frame: Baseline to 6 months
Change in PLE symptoms
Change in symptoms of protein losing enteropathy as determined by the protein losing enteropathy assessment tool (PLEAT) at multiple time points from baseline to 6 months after initiation of additional treatment (dopamine and control)
Time frame: baseline to 6 months
Change in quality of life
Change in quantitative quality of life metrics as assessed by the Pediatric Quality of Life Inventory (PedsQL) at multiple time points from baseline to 6 months after initiation of additional treatment (dopamine and control)
Time frame: baseline to 6 months
Plan to share: No — Inadequate enrollment
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in May 2025, 72 months.
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This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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