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Lymphatic Function in Patients With a Fontan Circulation From Brazil

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Lymphatic Abnormalities
Univentricular Heart
Lymphatic Edema

Treatments

Diagnostic Test: Strain Gauge Plethysmography
Diagnostic Test: Near-Infrared Fluorescence imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04394507
Fontan Brazil

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Fontan circulation
  • Age above 16.

Exclusion criteria

  • Mental illness
  • Syndromes.

Trial design

48 participants in 2 patient groups

Fontan Patients
Description:
Fontan patients operated at the two centres between 1991 and 2014.
Treatment:
Diagnostic Test: Near-Infrared Fluorescence imaging
Diagnostic Test: Strain Gauge Plethysmography
Control Group
Description:
Age, gender and weight matched healthy controls.
Treatment:
Diagnostic Test: Near-Infrared Fluorescence imaging
Diagnostic Test: Strain Gauge Plethysmography

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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