Univentricular HeartNCT04394507
Lymphatic Function in Patients With a Fontan Circulation From Brazil
An observational study of Univentricular Heart and Lymphatic Abnormalities, run by University of Aarhus at 2 sites in Denmark.
Trial summary
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Univentricular Heart, Lymphatic Abnormalities, Lymphatic Edema
- What is being tested?
- Near-Infrared Fluorescence imaging and Strain Gauge Plethysmography
- How many people
- 48 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2018to 1 May 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.
Who may be able to join
- Fontan circulation
- Age above 16.
Who cannot join
- Mental illness
- Syndromes.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University
Aarhus C, Danmark, 8000
Aarhus University Hospital
Aarhus N, Central Jutland, 8200
About this study
Official title: Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE).
An explorative study from our department at Aarhus University Hospital revealed that the function of the lymphatic vasculature in 10 young Fontan patients with no complications was abnormal compared to healthy controls. However, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of Fontan patients.
The hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and PLE.
Read the detailed description
The study population is patients with a Fontan circulation followed at InCor Heart Institute in Sao Paolo and Ribeirão Preto, Brazil. These were matched with and group of healthy controls.
The functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (NIRF) imaging. The capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. Furthermore, plasma concentration of noradrenaline will be estimated.
- Being tested
- Near-Infrared Fluorescence imaging, Strain Gauge Plethysmography
- Keywords
- Lymphatic dysfunction, Near-Infrared Fluorescence Imaging, Fontan Circulation, Plethysmography
- Medical subject headings
- Univentricular Heart, Lymphatic Abnormalities, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Fluorescence imagingDiagnostic test
.Near-infrared imaging was used to evaluate the function of the superficial lymphatic vessels in the right lower leg and foot as previously described.doi: 10.1161/CIRCIMAGING.118.008074.
Strain Gauge PlethysmographyDiagnostic test
Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb
| Study group | Role | What they receive |
|---|---|---|
| Fontan Patients | Fontan patients operated at the two centres between 1991 and 2014. Receives: Diagnostic Test: Near-Infrared Fluorescence imaging; Diagnostic Test: Strain Gauge Plethysmography | |
| Control Group | Age, gender and weight matched healthy controls. Receives: Diagnostic Test: Near-Infrared Fluorescence imaging; Diagnostic Test: Strain Gauge Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
Contraction frequency (contraction/minut)
Measured: 1 hour
Lymphatic function assessed by Near-Infrared fluorescence Imaging 2
Pumping Pressure (mmHg)
Measured: 1 hour
Lymphatic function assessed by Near-Infrared fluorescence Imaging 3
Packet Velocity
Measured: 1 hour
Secondary outcomes (1)
Capillary Filtration Rate measured by Strain Gauge Plethysmography
Capillary Filtration Rate
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 posted19 May 2020
- Study start1 Jul 2018
- Primary completion1 Sep 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies 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
- 48 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, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Vibeke Hjortdal, MD, PhD, Dmsc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394507
- Sponsor's protocol ID
- Fontan Brazil
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
- ClinicalTrials.gov ID
- NCT04394507
- Acronym / sponsor ID
- Fontan Brazil
- Keywords
- Lymphatic dysfunction, Near-Infrared Fluorescence Imaging, Fontan Circulation, Plethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Hospital das Clínicas de Ribeirão Preto, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 19 May 2020 (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.
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE).
An explorative study from our department at Aarhus University Hospital revealed that the function of the lymphatic vasculature in 10 young Fontan patients with no complications was abnormal compared to healthy controls. However, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of Fontan patients.
The hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and PLE.
Detailed description
The study population is patients with a Fontan circulation followed at InCor Heart Institute in Sao Paolo and Ribeirão Preto, Brazil. These were matched with and group of healthy controls.
The functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (NIRF) imaging. The capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. Furthermore, plasma concentration of noradrenaline will be estimated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan Patients | – | Diagnostic Test: Near-Infrared Fluorescence imaging, Diagnostic Test: Strain Gauge PlethysmographyFontan patients operated at the two centres between 1991 and 2014. |
| Control Group | – | Diagnostic Test: Near-Infrared Fluorescence imaging, Diagnostic Test: Strain Gauge PlethysmographyAge, gender and weight matched healthy controls. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.
Key inclusion criteria (2 listed)
- Fontan circulation
- Age above 16.
Key exclusion criteria (2 listed)
- Mental illness
- 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 |
|---|---|---|
| Near-Infrared Fluorescence imaging.Near-infrared imaging was used to evaluate the function of the superficial lymphatic vessels in the right lower leg and foot as previously described.doi: 10.1161/CIRCIMAGING.118.008074. | Diagnostic test | Control Group, Fontan Patients |
| Strain Gauge PlethysmographyStrain Gauge Plethysmography to asses capillary filtration rate og the lower limb | Diagnostic test | Control Group, Fontan Patients |
Primary outcome
Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
Time frame: 1 hour
Contraction frequency (contraction/minut)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 2
Time frame: 1 hour
Pumping Pressure (mmHg)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 3
Time frame: 1 hour
Packet Velocity
1 secondary outcome
Capillary Filtration Rate measured by Strain Gauge Plethysmography
Time frame: 1 hour
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 19 May 2020.
- Individual participant dataSharing planned: No
Related trials for Univentricular Heart
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Enrolling by invitationObservational study
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
Congenital Heart Disease
Recruiting
Venous Compression in Fontan
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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 Hjortdal, MD, PhD, Dmsc study director
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Univentricular Heart and Lymphatic Abnormalities, run by University of Aarhus at 2 sites 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 2 inclusion and 2 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 function assessed by Near-Infrared fluorescence Imaging 1 (time frame: 1 hour). The study lists 3 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 19 May 2020.