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Lymphatic Morphology of Fontan Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163653
Recruitment Status : Active, not recruiting
First Posted : November 15, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
InCor Heart Institute
Hospital das Clínicas de Ribeirão Preto
Information provided by (Responsible Party):
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment
Lymphatic Abnormality Plastic Bronchitis Protein-Losing Enteropathies Univentricular Heart Congenital Heart Disease Diagnostic Test: Non-contrast MRI Diagnostic Test: Cardiopulmonary exercise test

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Lymphatic Morphology and Classification in Patients With a Fontan Circulation - A Multicenter Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fontan Group
Fontan patients operated at the two centres between 1991 and 2014.
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.

Healthy Control Group
Age, gender and weight matched healthy controls.
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a Fontan circulation.
Criteria

Inclusion Criteria:

- Fontan Circulation

Exclusion Criteria:

  • Age <18 years
  • Mental illness
  • Genetic syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163653


Locations
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Denmark
Department of Cardiothoracic and Vascular Surgery
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
InCor Heart Institute
Hospital das Clínicas de Ribeirão Preto

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04163653    
Other Study ID Numbers: BRALYMF
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Protein-Losing Enteropathies
Bronchitis
Heart Diseases
Lymphatic Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lymphatic Diseases