Lymphatic Function in Patients With a Fontan Circulation From Brazil

Lymphatic Function and Interstitial Fluid Filtration 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.

Study Overview

• Status: Completed
• Conditions: Univentricular Heart; Lymphatic Abnormalities; Lymphatic Edema
• Intervention / Treatment: Diagnostic test: Near-Infrared Fluorescence imaging; Diagnostic test: Strain Gauge Plethysmography

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus N, Central Denmark Region, Denmark, 8200
      • Aarhus University Hospital
  • Danmark
    • Aarhus C, Danmark, Denmark, 8000
      • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.

Description

Inclusion Criteria:

• Fontan circulation
• Age above 16.

Exclusion Criteria:

• Mental illness
• Syndromes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fontan Patients; Fontan patients operated at the two centres between 1991 and 2014.	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
Control Group; Age, gender and weight matched healthy controls.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Rigshospitalet, Denmark; InCor Heart Institute; Hospital das Clínicas de Ribeirão Preto
• Investigators: Study Director: Vibeke Hjortdal, MD, PhD, Dmsc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Near-Infrared Fluorescence Imaging; Plethysmography; Lymphatic dysfunction; Fontan Circulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Lymphatic Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Univentricular Heart; Lymphatic Abnormalities
• Other Study ID Numbers: Fontan Brazil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No