Lymphatic Morphology of Fontan Patients

NCT04163653 | Completed DMC

• 1 other identifier: BRALYMF
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Lymphatic classification

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

  1 hour

• Relative measure of tortuosity

  Straight length/full length (mm/mm)

  1 hour

• Measurement of thoracic duct volume

  Volume (mm\^2)

  1 hour

• Measurement of thoracic duct diameter

  Diameter at inlet (mm)

  1 hour

• 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

• CPX heart rate

  Maximum heart rate (bpm)

  1 hour

• CPX Vo2

  VO2 max

  1 hour

Study Arms (2)

Fontan Group

Fontan patients operated at the two centres between 1991 and 2014.

Diagnostic Test: Non-contrast MRI; Diagnostic Test: Cardiopulmonary exercise test

Healthy Control Group

Age, gender and weight matched healthy controls.

Diagnostic Test: Non-contrast MRI; Diagnostic Test: Cardiopulmonary exercise test

Interventions

Non-contrast MRI DIAGNOSTIC_TEST

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

Fontan Group; Healthy Control Group

Cardiopulmonary exercise test DIAGNOSTIC_TEST

Cardiopulmonary exercise test, measurement of VO2 and heart rate.

Fontan Group; Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a Fontan circulation.

You may qualify if:

• \- Fontan Circulation

You may not qualify if:

• Age \<18 years
• Mental illness
• Genetic syndromes

Sponsors & Collaborators

• University of Aarhus: lead
• InCor Heart Institute: collaborator
• Hospital das Clínicas de Ribeirão Preto: collaborator

Study Sites (1)

Department of Cardiothoracic and Vascular Surgery

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Lymphatic Abnormalities; Protein-Losing Enteropathies; Univentricular Heart; Heart Defects, Congenital

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 15, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: June 18, 2023

Record last verified: 2021-04

Locations

DK (1)