Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04163653 |
Other study ID # |
BRALYMF |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2018 |
Est. completion date |
January 1, 2022 |
Study information
Verified date |
April 2021 |
Source |
University of Aarhus |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
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. It has been proposed that these complications arise due to a elevated central venous
pressure of the changed circulation.
The hypothesis of the study 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. The main lymphatic
vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic
changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published
grading system. The above will be correlated with the amount of complications experienced by
the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.
The study population consists of patients with a Fontan circulation operated at InCor Heart
Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion
criteria were mental illness, genetic syndromes and age <18 years. The patient group will be
compared with age, gender and weight matched healthy controls.