Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

Univentricular Heart Clinical Trial

Official title:

The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03379805
• Other study ID #: Fontan17
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2017
• Last updated: December 19, 2017
• Start date: April 25, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 31, 2018
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fontan-Kreutzer circulation

Exclusion Criteria:

• BMI>30,

• Age<18

• Mental illness

Related Conditions & MeSH terms

• Lymphatic Abnormalities
• Lymphatic Edema
• Lymphedema
• Univentricular Heart

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pumping pressure	Occlusion of lymphatic flow by inflating a cuff (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source) to 70mmHg and then reducing the pressure with 5mmHg each 5th minute. The highest pressure under which the fluorescent dye is able to cross the inflatable cuff is labelled Ppump.	1 hour
Primary	Contraction Frequency	Contraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus.	6 min
Primary	Refill time	The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage	20 min
Primary	Velocity	The velocity measured in cm/s for a packet of lymph moving from one region of interest (ROI) to another through atlas a 5 cm straight vessel	6 min
Primary	Capillary Filtration Rate	A 5-step 20-min venous congestion protocol will be used to measure capillary filtration. The capillary filtration rate (µl·100 ml-1 ·min-1 ) is measured as the slope of the time-volume change (%) curve at steady state at the end of each pressure phase.	25 min