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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04394507

Enrollment

Registered

2020-05-19

Start date

2018-07-01

Completion date

2019-05-01

Last updated

2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Univentricular Heart, Lymphatic Abnormalities, Lymphatic Edema

Keywords

Lymphatic dysfunction, Near-Infrared Fluorescence Imaging, Fontan Circulation, Plethysmography

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.

Interventions

DIAGNOSTIC_TESTNear-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_TESTStrain Gauge Plethysmography

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Fontan circulation * Age above 16.

Exclusion criteria

* Mental illness * Syndromes.

Design outcomes

Primary

Measure	Time frame	Description
Lymphatic function assessed by Near-Infrared fluorescence Imaging 1	1 hour	Contraction frequency (contraction/minut)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 2	1 hour	Pumping Pressure (mmHg)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 3	1 hour	Packet Velocity

Secondary

Measure	Time frame	Description
Capillary Filtration Rate measured by Strain Gauge Plethysmography	1 hour	Capillary Filtration Rate

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026