Univentricular Heart Clinical Trial
Official title:
Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
NCT number | NCT04394507 |
Other study ID # | Fontan Brazil |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | May 1, 2019 |
Verified date | May 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | May 1, 2019 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Fontan circulation - Age above 16. Exclusion Criteria: - Mental illness - Syndromes. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus C | Danmark |
Denmark | Aarhus University Hospital | Aarhus N | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Hospital das Clínicas de Ribeirão Preto, InCor Heart Institute, Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lymphatic function assessed by Near-Infrared fluorescence Imaging 1 | Contraction frequency (contraction/minut) | 1 hour | |
Primary | Lymphatic function assessed by Near-Infrared fluorescence Imaging 2 | Pumping Pressure (mmHg) | 1 hour | |
Primary | Lymphatic function assessed by Near-Infrared fluorescence Imaging 3 | Packet Velocity | 1 hour | |
Secondary | Capillary Filtration Rate measured by Strain Gauge Plethysmography | Capillary Filtration Rate | 1 hour |
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