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Completed

NCT Number: NCT04163653

Lymphatic Morphology of Fontan Patients

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.

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Key information

Conditions

Lymphatic Abnormality Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Heart Defects, Congenital Heart Diseases Hemic and Lymphatic Diseases Intestinal Diseases Lymphatic Abnormalities Lymphatic Diseases Plastic Bronchitis Protein-Losing Enteropathies Univentricular Heart

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiothoracic and Vascular Surgery

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fontan Circulation

Exclusion criteria

  • Age <18 years
  • Mental illness
  • Genetic syndromes

Treatment and study plan

Non-contrast MRI

Diagnostic Test

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

cardiopulmonary exercise test

Diagnostic Test

Cardiopulmonary exercise test, measurement of VO2 and heart rate.

Primary outcomes

  1. Lymphatic classification

    Time frame: 1 hour

    Classified by third party, according to following: (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542623/)

  2. Relative measure of tortuosity

    Time frame: 1 hour

    Straight length/full length (mm/mm)

  3. Measurement of thoracic duct volume

    Time frame: 1 hour

    Volume (mm^2)

  4. Measurement of thoracic duct diameter

    Time frame: 1 hour

    Diameter at inlet (mm)

  5. The International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: 1 hour

    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.

  6. CPX heart rate

    Time frame: 1 hour

    Maximum heart rate (bpm)

  7. CPX Vo2

    Time frame: 1 hour

    VO2 max

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Hospital das Clínicas de Ribeirão Preto
  • InCor Heart Institute

Registry information

Official study title

Lymphatic Morphology and Classification in Patients With a Fontan Circulation - A Multicenter Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Nov 15, 2019
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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