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Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

NCT03379805 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2017-12-20

No results posted yet for this study

Summary

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.

Our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography.

Conditions

  • Lymphatic Abnormalities
  • Lymphatic Edema
  • Univentricular Heart

Interventions

DIAGNOSTIC_TEST

Near Infrared Fluorescence Imaging

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.

DIAGNOSTIC_TEST

Non-contrast MRI

The anatomy is described using non-contrast MRI.

DIAGNOSTIC_TEST

Strain Gauge Plethysmography

The capillary filtration rate is measured using plethysmography

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Vibeke E Hjortdal, MD, PhD, Dr.Med · Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-25
Primary Completion
2017-06-20
Completion
2018-08-31

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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 NCT03379805 on ClinicalTrials.gov