Lymphatic AbnormalityNCT04163653
Lymphatic Morphology of Fontan Patients
An observational study of Lymphatic Abnormality and Plastic Bronchitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Abnormality, Plastic Bronchitis, Protein-Losing Enteropathies
- What is being tested?
- Non-contrast MRI and Cardiopulmonary exercise test
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 1 Jan 2022
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a Fontan circulation.
Who may be able to join
- Fontan Circulation
Who cannot join
- Age <18 years
- Mental illness
- Genetic syndromes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic and Vascular Surgery
Aarhus N, 8200
About this study
Official title: Lymphatic Morphology and Classification in Patients With a Fontan Circulation - A Multicenter Study
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema.
The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI.
Read the detailed description
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. It has been proposed that these complications arise due to a elevated central venous pressure of the changed circulation.
The hypothesis of the study is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI. The main lymphatic vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published grading system. The above will be correlated with the amount of complications experienced by the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.
The study population consists of patients with a Fontan circulation operated at InCor Heart Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion criteria were mental illness, genetic syndromes and age <18 years. The patient group will be compared with age, gender and weight matched healthy controls.
- Conditions
- Lymphatic Abnormality, Plastic Bronchitis, Protein-Losing Enteropathies, Univentricular Heart, Congenital Heart Disease
- Being tested
- Non-contrast MRI, Cardiopulmonary exercise test
- Medical subject headings
- Lymphatic Abnormalities, Protein-Losing Enteropathies, Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast MRIDiagnostic test
Classification and characterization of the lymphatic vasculature using non-contrast MRI.
Cardiopulmonary exercise testDiagnostic test
Cardiopulmonary exercise test, measurement of VO2 and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Fontan Group | Fontan patients operated at the two centres between 1991 and 2014. Receives: Diagnostic Test: Non-contrast MRI; Diagnostic Test: Cardiopulmonary exercise test | |
| Healthy Control Group | Age, gender and weight matched healthy controls. Receives: Diagnostic Test: Non-contrast MRI; Diagnostic Test: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic classification
Classified by third party, according to following: (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542623/)
Measured: 1 hour
Relative measure of tortuosity
Straight length/full length (mm/mm)
Measured: 1 hour
Measurement of thoracic duct volume
Volume (mm^2)
Measured: 1 hour
Measurement of thoracic duct diameter
Diameter at inlet (mm)
Measured: 1 hour
The International Physical Activity Questionnaire (IPAQ-SF)
IPAQ-SF estimation of weekly activity. (Total Physical Activity min/wk: 2 × time spent on vigorous + moderate + walking) Higher value equals higher level of activity.
Measured: 1 hour
CPX heart rate
Maximum heart rate (bpm)
Measured: 1 hour
CPX Vo2
VO2 max
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic AbnormalityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Hospital das Clínicas de Ribeirão Preto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163653
- Sponsor's protocol ID
- BRALYMF
- Status last verified
- Apr 2021
- First submitted
- 11 Nov 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Morphology and Classification in Patients With a Fontan Circulation - A Multicenter Study
- ClinicalTrials.gov ID
- NCT04163653
- Acronym / sponsor ID
- BRALYMF
- Conditions
- Lymphatic Abnormality, Plastic Bronchitis, Protein-Losing Enteropathies, Univentricular Heart, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Hospital das Clínicas de Ribeirão Preto
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 Nov 2019 (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 Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema.
The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI.
Detailed description
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. It has been proposed that these complications arise due to a elevated central venous pressure of the changed circulation.
The hypothesis of the study is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.
The morphology will be described using T2-weighted non-contrast MRI. The main lymphatic vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published grading system. The above will be correlated with the amount of complications experienced by the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.
The study population consists of patients with a Fontan circulation operated at InCor Heart Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion criteria were mental illness, genetic syndromes and age <18 years. The patient group will be compared with age, gender and weight matched healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan Group | – | Diagnostic Test: Non-contrast MRI, Diagnostic Test: Cardiopulmonary exercise testFontan patients operated at the two centres between 1991 and 2014. |
| Healthy Control Group | – | Diagnostic Test: Non-contrast MRI, Diagnostic Test: Cardiopulmonary exercise testAge, gender and weight matched healthy controls. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Fontan circulation.
Key inclusion criteria (1 listed)
- Fontan Circulation
Key exclusion criteria (3 listed)
- Age <18 years
- Mental illness
- Genetic syndromes
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 |
|---|---|---|
| Non-contrast MRIClassification and characterization of the lymphatic vasculature using non-contrast MRI. | Diagnostic test | Fontan Group, Healthy Control Group |
| Cardiopulmonary exercise testCardiopulmonary exercise test, measurement of VO2 and heart rate. | Diagnostic test | Fontan Group, Healthy Control Group |
Primary outcome
Lymphatic classification
Time frame: 1 hour
Classified by third party, according to following: (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542623/)
Relative measure of tortuosity
Time frame: 1 hour
Straight length/full length (mm/mm)
Measurement of thoracic duct volume
Time frame: 1 hour
Volume (mm^2)
Measurement of thoracic duct diameter
Time frame: 1 hour
Diameter at inlet (mm)
The International Physical Activity Questionnaire (IPAQ-SF)
Time frame: 1 hour
IPAQ-SF estimation of weekly activity. (Total Physical Activity min/wk: 2 × time spent on vigorous + moderate + walking) Higher value equals higher level of activity.
CPX heart rate
Time frame: 1 hour
Maximum heart rate (bpm)
CPX Vo2
Time frame: 1 hour
VO2 max
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Abnormality and Plastic Bronchitis, run by University of Aarhus at 1 site in Denmark.
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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lymphatic classification (time frame: 1 hour). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.