Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

University of Aarhus

Status: Unknown

Conditions: Univentricular Heart; Lymphatic Abnormalities; Lymphatic Edema

Treatments: Diagnostic Test: Non-contrast MRI; Diagnostic Test: Strain Gauge Plethysmography; Diagnostic Test: Near Infrared Fluorescence Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03379805

Fontan17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fontan-Kreutzer circulation

Exclusion criteria

• BMI>30,
• Age<18
• Mental illness

Trial design

10 participants in 2 patient groups

Fontan-Kreutzer operated patients

Description:

Patients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago)

Treatment:

Diagnostic Test: Non-contrast MRI

Diagnostic Test: Near Infrared Fluorescence Imaging

Diagnostic Test: Strain Gauge Plethysmography

Healthy Control subjects

Description:

Age, gender and weight matched control subjects

Treatment:

Diagnostic Test: Non-contrast MRI

Diagnostic Test: Near Infrared Fluorescence Imaging

Diagnostic Test: Strain Gauge Plethysmography