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Lymphatic Function in Patients With a Fontan Circulation From Brazil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394507
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
InCor Heart Institute
Hospital das Clínicas de Ribeirão Preto
Rigshospitalet, Denmark
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Univentricular Heart Lymphatic Abnormalities Lymphatic Edema 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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : May 1, 2019


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Capillary Filtration Rate measured by Strain Gauge Plethysmography [ Time Frame: 1 hour ]
    Capillary Filtration Rate



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.
Criteria

Inclusion Criteria:

  • Fontan circulation
  • Age above 16.

Exclusion Criteria:

  • Mental illness
  • Syndromes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394507


Locations
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Denmark
Aarhus University Hospital
Aarhus N, Central Denmark Region, Denmark, 8200
Aarhus University
Aarhus C, Danmark, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
InCor Heart Institute
Hospital das Clínicas de Ribeirão Preto
Rigshospitalet, Denmark
Investigators
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Study Director: Vibeke Hjortdal, MD, PhD, Dmsc Rigshospitalet, Denmark
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04394507    
Other Study ID Numbers: Fontan Brazil
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Lymphatic dysfunction
Near-Infrared Fluorescence Imaging
Fontan Circulation
Plethysmography
Additional relevant MeSH terms:
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Lymphatic Abnormalities
Congenital Abnormalities
Lymphatic Diseases