An observational study in Univentricular Heart, Lymphatic Abnormalities and Lymphatic Edema, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by University of Aarhus · Observational
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.
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.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
This study's enrollment of 48 is above the median of 42 across 37 observational studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.
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Exclusion Criteria:
Fontan patients operated at the two centres between 1991 and 2014.
Diagnostic Test: Near-Infrared Fluorescence imaging · Diagnostic Test: Strain Gauge Plethysmography
Age, gender and weight matched healthy controls.
Diagnostic Test: Near-Infrared Fluorescence imaging · Diagnostic Test: Strain Gauge Plethysmography
.Near-infrared imaging was used to evaluate the function of the superficial lymphatic vessels in the right lower leg and foot as previously described.doi: 10.1161/CIRCIMAGING.118.008074.
Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb
Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
Contraction frequency (contraction/minut)
Time frame: 1 hour
Lymphatic function assessed by Near-Infrared fluorescence Imaging 2
Pumping Pressure (mmHg)
Time frame: 1 hour
Lymphatic function assessed by Near-Infrared fluorescence Imaging 3
Packet Velocity
Time frame: 1 hour
Capillary Filtration Rate measured by Strain Gauge Plethysmography
Capillary Filtration Rate
Time frame: 1 hour
Plan to share: No
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Ran from Jul 2018 to primary completion in Sep 2018, 2 months.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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