NCT04394507

Lymphatic Function in Patients With a Fontan Circulation From Brazil

Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Univentricular Heart
• Lymphatic Abnormalities
• Lymphatic Edema

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Near-Infrared Fluorescence imaging	.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.
DIAGNOSTIC_TEST	Strain Gauge Plethysmography	Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-09-01
• Completion: 2019-05-01
• First posted: 2020-05-19
• Last updated: 2020-05-19

Locations

2 sites across 1 country: Denmark