Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

NCT03379805 | Unknown DMC

• 1 other identifier: Fontan17
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Pumping pressure

  Occlusion of lymphatic flow by inflating a cuff (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source) to 70mmHg and then reducing the pressure with 5mmHg each 5th minute. The highest pressure under which the fluorescent dye is able to cross the inflatable cuff is labelled Ppump.

  1 hour

• Contraction Frequency

  Contraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus.

  6 min

• Refill time

  The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage

  20 min

• Velocity

  The velocity measured in cm/s for a packet of lymph moving from one region of interest (ROI) to another through atlas a 5 cm straight vessel

  6 min

• Capillary Filtration Rate

  A 5-step 20-min venous congestion protocol will be used to measure capillary filtration. The capillary filtration rate (µl·100 ml-1 ·min-1 ) is measured as the slope of the time-volume change (%) curve at steady state at the end of each pressure phase.

  25 min

Study Arms (2)

Fontan-Kreutzer operated patients

Patients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago)

Diagnostic Test: Near Infrared Fluorescence Imaging; Diagnostic Test: Non-contrast MRI; Diagnostic Test: Strain Gauge Plethysmography

Healthy Control subjects

Age, gender and weight matched control subjects

Diagnostic Test: Near Infrared Fluorescence Imaging; Diagnostic Test: Non-contrast MRI; Diagnostic Test: Strain Gauge Plethysmography

Interventions

Near Infrared Fluorescence Imaging DIAGNOSTIC_TEST

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

Also known as: Strain-Gauge Plethysmography

Fontan-Kreutzer operated patients; Healthy Control subjects

Non-contrast MRI DIAGNOSTIC_TEST

The anatomy is described using non-contrast MRI.

Fontan-Kreutzer operated patients; Healthy Control subjects

Strain Gauge Plethysmography DIAGNOSTIC_TEST

The capillary filtration rate is measured using plethysmography

Fontan-Kreutzer operated patients; Healthy Control subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation

You may qualify if:

• Fontan-Kreutzer circulation

You may not qualify if:

• BMI\>30,
• Age\<18
• Mental illness

Sponsors & Collaborators

• University of Aarhus: lead

Related Publications (1)

• Mohanakumar S, Telinius N, Kelly B, Lauridsen H, Boedtkjer D, Pedersen M, de Leval M, Hjortdal V. Morphology and Function of the Lymphatic Vasculature in Patients With a Fontan Circulation. Circ Cardiovasc Imaging. 2019 Apr;12(4):e008074. doi: 10.1161/CIRCIMAGING.118.008074.

  PMID: 30943769 DERIVED

MeSH Terms

Conditions

Lymphatic Abnormalities; Lymphedema; Univentricular Heart

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Study Officials

• Vibeke E Hjortdal, MD, PhD, Dr.Med

  Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 20, 2017
• Study Start: April 25, 2014
• Primary Completion: June 20, 2017
• Study Completion: August 31, 2018
• Last Updated: December 20, 2017

Record last verified: 2017-12