NCT03379805

Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation. Our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE. The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography.

Detailed description

Background: The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation. Hypothesis: Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE. Material and Methods: The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI\>30 and age (years) \< 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.

Conditions

• Lymphatic Abnormalities
• Lymphatic Edema
• Univentricular Heart

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Near Infrared Fluorescence Imaging	The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
DIAGNOSTIC_TEST	Non-contrast MRI	The anatomy is described using non-contrast MRI.
DIAGNOSTIC_TEST	Strain Gauge Plethysmography	The capillary filtration rate is measured using plethysmography

Timeline

• Start date: 2014-04-25
• Primary completion: 2017-06-20
• Completion: 2018-08-31
• First posted: 2017-12-20
• Last updated: 2017-12-20