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Search / Trial NCT03322345

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

Launched by UNIVERSITY OF MICHIGAN · Oct 23, 2017

Trial Information

Current as of July 01, 2025

Enrolling by invitation

Keywords

Lymph Flow Fontan

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

  • 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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Kurt Schumacher, MD, MS

Principal Investigator

University of Michigan Division of Pediatric Cardiology

Joshua Meisner, MD, PhD

Principal Investigator

University of Michigan Division of Pediatric Cardiology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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