Clinical trial NCT04394507: Lymphatic Function in Patients With a Fontan Circulation From Brazil
Official title: Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Univentricular Heart
Lymphatic Abnormalities
Lymphatic Edema
Keywords: Lymphatic dysfunction
Near-Infrared Fluorescence Imaging
Fontan Circulation
Plethysmography
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Hospital das Clínicas de Ribeirão Preto
name: Rigshospitalet, Denmark
First posted: 2020-05-19
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.

Brief summary: It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE).

An explorative study from our department at Aarhus University Hospital revealed that the function of the lymphatic vasculature in 10 young Fontan patients with no complications was abnormal compared to healthy controls. However, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of Fontan patients.

The hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and PLE.

Detailed description: The study population is patients with a Fontan circulation followed at InCor Heart Institute in Sao Paolo and Ribeirão Preto, Brazil. These were matched with and group of healthy controls.

The functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (NIRF) imaging. The capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. Furthermore, plasma concentration of noradrenaline will be estimated.

Eligibility criteria: Inclusion Criteria:

* Fontan circulation
* Age above 16.

Exclusion Criteria:

* Mental illness
* Syndromes.

Primary outcomes:
measure: Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
timeFrame: 1 hour
measure: Lymphatic function assessed by Near-Infrared fluorescence Imaging 2
timeFrame: 1 hour
measure: Lymphatic function assessed by Near-Infrared fluorescence Imaging 3
timeFrame: 1 hour
Secondary outcomes:
measure: Capillary Filtration Rate measured by Strain Gauge Plethysmography
timeFrame: 1 hour
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Aarhus C
country: Denmark
facility: Aarhus University
state: Danmark
Study officials:
affiliation: Rigshospitalet, Denmark
name: Vibeke Hjortdal, MD, PhD, Dmsc
role: STUDY_DIRECTOR
References: