Clinical trial NCT03379805: Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
Official title: The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphatic Abnormalities
Lymphatic Edema
Univentricular Heart
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Fontan-Kreutzer circulation

Exclusion Criteria:

* BMI\>30,
* Age\<18
* Mental illness

Primary outcomes:
measure: Pumping pressure
timeFrame: 1 hour
measure: Contraction Frequency
timeFrame: 6 min
measure: Refill time
timeFrame: 20 min
measure: Velocity
timeFrame: 6 min
measure: Capillary Filtration Rate
timeFrame: 25 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery
name: Vibeke E Hjortdal, MD, PhD, Dr.Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohanakumar S, Telinius N, Kelly B, Lauridsen H, Boedtkjer D, Pedersen M, de Leval M, Hjortdal V. Morphology and Function of the Lymphatic Vasculature in Patients With a Fontan Circulation. Circ Cardiovasc Imaging. 2019 Apr;12(4):e008074. doi: 10.1161/CIRCIMAGING.118.008074.