Lymphatic Function in Patients With a Fontan Circulation From Brazil

NCT04394507 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2020-05-19

No results posted yet for this study

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.

Conditions

  • Univentricular Heart
  • Lymphatic Abnormalities
  • Lymphatic Edema

Interventions

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

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER
  • Hospital das Clínicas de Ribeirão Preto

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Vibeke Hjortdal, MD, PhD, Dmsc · Rigshospitalet, Denmark

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2018-09-01
Completion
2019-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394507 on ClinicalTrials.gov