Lymphatic Function in Patients With a Fontan Circulation From Brazil

Univentricular Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394507
• Other study ID #: Fontan Brazil
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Fontan circulation

• Age above 16.

Exclusion Criteria:

• Mental illness

• Syndromes.

Related Conditions & MeSH terms

• Lymphatic Abnormalities
• Lymphatic Edema
• Univentricular Heart

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus C	Danmark
Denmark	Aarhus University Hospital	Aarhus N	Central Denmark Region

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Hospital das Clínicas de Ribeirão Preto, InCor Heart Institute, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphatic function assessed by Near-Infrared fluorescence Imaging 1	Contraction frequency (contraction/minut)	1 hour
Primary	Lymphatic function assessed by Near-Infrared fluorescence Imaging 2	Pumping Pressure (mmHg)	1 hour
Primary	Lymphatic function assessed by Near-Infrared fluorescence Imaging 3	Packet Velocity	1 hour
Secondary	Capillary Filtration Rate measured by Strain Gauge Plethysmography	Capillary Filtration Rate	1 hour