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NCT Number: NCT04394507

Lymphatic Function in Patients With a Fontan Circulation From Brazil

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.

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Key information

Conditions

Univentricular Heart Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hemic and Lymphatic Diseases Lymphatic Abnormalities Lymphatic Diseases Lymphatic Edema Lymphedema

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus N, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fontan circulation
  • Age above 16.

Exclusion criteria

  • Mental illness
  • Syndromes.

Treatment and study plan

Near-Infrared Fluorescence imaging

Diagnostic Test

.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

Diagnostic Test

Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb

Primary outcomes

  1. Lymphatic function assessed by Near-Infrared fluorescence Imaging 1

    Time frame: 1 hour

    Contraction frequency (contraction/minut)

  2. Lymphatic function assessed by Near-Infrared fluorescence Imaging 2

    Time frame: 1 hour

    Pumping Pressure (mmHg)

  3. Lymphatic function assessed by Near-Infrared fluorescence Imaging 3

    Time frame: 1 hour

    Packet Velocity

Secondary outcomes

  1. Capillary Filtration Rate measured by Strain Gauge Plethysmography

    Time frame: 1 hour

    Capillary Filtration Rate

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Hospital das Clínicas de Ribeirão Preto
  • InCor Heart Institute
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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