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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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date January 1, 2022
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Fontan Circulation Exclusion Criteria: - Age <18 years - Mental illness - Genetic syndromes

Study Design


Intervention

Diagnostic Test:
Non-contrast MRI
Classification and characterization of the lymphatic vasculature using non-contrast MRI.
Cardiopulmonary exercise test
Cardiopulmonary exercise test, measurement of VO2 and heart rate.

Locations

Country Name City State
Denmark Department of Cardiothoracic and Vascular Surgery Aarhus N

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Hospital das Clínicas de Ribeirão Preto, InCor Heart Institute

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lymphatic classification Classified by third party, according to following: (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542623/) 1 hour
Primary Relative measure of tortuosity Straight length/full length (mm/mm) 1 hour
Primary Measurement of thoracic duct volume Volume (mm^2) 1 hour
Primary Measurement of thoracic duct diameter Diameter at inlet (mm) 1 hour
Primary The International Physical Activity Questionnaire (IPAQ-SF) IPAQ-SF estimation of weekly activity. (Total Physical Activity min/wk: 2 × time spent on vigorous + moderate + walking) Higher value equals higher level of activity. 1 hour
Primary CPX heart rate Maximum heart rate (bpm) 1 hour
Primary CPX Vo2 VO2 max 1 hour
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