Lymphatic Function in Patients With a Fontan Circulation From Brazil

Completed

• Conditions: Lymphatic Abnormalities; Univentricular Heart; Lymphatic Edema
• Interventions: Diagnostic Test: Near-Infrared Fluorescence imaging; Diagnostic Test: Strain Gauge Plethysmography

• Registration Number: NCT04394507
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-05-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Fontan circulation
• Age above 16.

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Exclusion Criteria

• Mental illness
• Syndromes.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Capillary Filtration Rate measured by Strain Gauge Plethysmography	1 hour	Capillary Filtration Rate

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus N, Central Denmark Region, Denmark

Aarhus University; 🇩🇰 Aarhus C, Danmark, Denmark