Lymphatic AbnormalitiesNCT03379805
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
An observational study of Lymphatic Abnormalities and Lymphatic Edema, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Abnormalities, Lymphatic Edema, Univentricular Heart
- What is being tested?
- Near Infrared Fluorescence Imaging, Non-contrast MRI and Strain Gauge Plethysmography
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2014to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation
Who may be able to join
- Fontan-Kreutzer circulation
Who cannot join
- BMI>30,
- Age<18
- Mental illness
About this study
Official title: The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
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.
Read the 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.
- Being tested
- Near Infrared Fluorescence Imaging, Non-contrast MRI, Strain Gauge Plethysmography
- Medical subject headings
- Lymphatic Abnormalities, Lymphedema, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Fluorescence ImagingDiagnostic test
Also called Strain-Gauge Plethysmography
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Non-contrast MRIDiagnostic test
The anatomy is described using non-contrast MRI.
Strain Gauge PlethysmographyDiagnostic test
The capillary filtration rate is measured using plethysmography
| Study group | Role | What they receive |
|---|---|---|
| Fontan-Kreutzer operated patients | Patients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago) Receives: 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 Receives: Diagnostic Test: Near Infrared Fluorescence Imaging; Diagnostic Test: Non-contrast MRI; Diagnostic Test: Strain Gauge Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 min
Refill time
The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
Measured: 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
Measured: 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.
Measured: 25 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start25 Apr 2014
- Primary completion20 Jun 2017
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphatic AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibeke E Hjortdal, MD, PhD, Dr.Med, Principal investigator, Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379805
- Sponsor's protocol ID
- Fontan17
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30943769
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
- ClinicalTrials.gov ID
- NCT03379805
- Acronym / sponsor ID
- Fontan17
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 25 Apr 2014 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan-Kreutzer operated patients | – | Diagnostic Test: Near Infrared Fluorescence Imaging, Diagnostic Test: Non-contrast MRI, Diagnostic Test: Strain Gauge PlethysmographyPatients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago) |
| Healthy Control subjects | – | Diagnostic Test: Near Infrared Fluorescence Imaging, Diagnostic Test: Non-contrast MRI, Diagnostic Test: Strain Gauge PlethysmographyAge, gender and weight matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation
Key inclusion criteria (1 listed)
- Fontan-Kreutzer circulation
Key exclusion criteria (3 listed)
- BMI>30,
- Age<18
- Mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared Fluorescence ImagingAlso: Strain-Gauge PlethysmographyThe functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. | Diagnostic test | Fontan-Kreutzer operated patients, Healthy Control subjects |
| Non-contrast MRIThe anatomy is described using non-contrast MRI. | Diagnostic test | Fontan-Kreutzer operated patients, Healthy Control subjects |
| Strain Gauge PlethysmographyThe capillary filtration rate is measured using plethysmography | Diagnostic test | Fontan-Kreutzer operated patients, Healthy Control subjects |
Primary outcome
Pumping pressure
Time frame: 1 hour
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.
Contraction Frequency
Time frame: 6 min
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.
Refill time
Time frame: 20 min
The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
Velocity
Time frame: 6 min
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
Capillary Filtration Rate
Time frame: 25 min
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Derived from this study: PubMed 30943769Mohanakumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke E Hjortdal, MD, PhD, Dr.Med principal investigator
Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Abnormalities and Lymphatic Edema, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pumping pressure (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.