Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-09 @ 2:48 PM
Study NCT ID:
NCT03379805
Status:
UNKNOWN
Last Update Posted:
2017-12-20
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Background:
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.
Hypothesis:
Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.
Material and Methods:
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. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI\>30 and age (years) \< 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.
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.
Hypothesis:
Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.
Material and Methods:
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. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI\>30 and age (years) \< 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: