MedTrace Logo

Lymphatic Morphology of Fontan Patients

NCT04163653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2023-06-18

No results posted yet for this study

Summary

The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema.

The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.

The morphology will be described using T2-weighted non-contrast MRI.

Conditions

  • Lymphatic Abnormality
  • Plastic Bronchitis
  • Protein-Losing Enteropathies
  • Univentricular Heart
  • Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

Non-contrast MRI

Classification and characterization of the lymphatic vasculature using non-contrast MRI.

DIAGNOSTIC_TEST

Cardiopulmonary exercise test

Cardiopulmonary exercise test, measurement of VO2 and heart rate.

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • Hospital das Clínicas de Ribeirão Preto

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-01-01
Completion
2022-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163653 on ClinicalTrials.gov