NCT04394507

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 14, 2020

Last Update Submit

May 18, 2020

Conditions

Univentricular HeartLymphatic AbnormalitiesLymphatic Edema

Keywords

Lymphatic dysfunctionNear-Infrared Fluorescence ImagingFontan CirculationPlethysmography

Outcome Measures

Primary Outcomes (3)

  • Lymphatic function assessed by Near-Infrared fluorescence Imaging 1

    Contraction frequency (contraction/minut)

    1 hour

  • Lymphatic function assessed by Near-Infrared fluorescence Imaging 2

    Pumping Pressure (mmHg)

    1 hour

  • Lymphatic function assessed by Near-Infrared fluorescence Imaging 3

    Packet Velocity

    1 hour

Secondary Outcomes (1)

  • Capillary Filtration Rate measured by Strain Gauge Plethysmography

    1 hour

Study Arms (2)

Fontan Patients

Fontan patients operated at the two centres between 1991 and 2014.

Diagnostic Test: Near-Infrared Fluorescence imagingDiagnostic Test: Strain Gauge Plethysmography

Control Group

Age, gender and weight matched healthy controls.

Diagnostic Test: Near-Infrared Fluorescence imagingDiagnostic Test: Strain Gauge Plethysmography

Interventions

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.

Control GroupFontan Patients
Strain Gauge PlethysmographyDIAGNOSTIC_TEST

Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb

Control GroupFontan Patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients born with a univentricular heart treated surgically with a Fontan circulation in early childhood.

You may qualify if:

  • Fontan circulation
  • Age above 16.

You may not qualify if:

  • Mental illness
  • Syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus N, Central Jutland, 8200, Denmark

Location

Aarhus University

Aarhus C, Danmark, 8000, Denmark

Location

MeSH Terms

Conditions

Univentricular HeartLymphatic AbnormalitiesLymphedema

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Vibeke Hjortdal, MD, PhD, Dmsc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

July 1, 2018

Primary Completion

September 1, 2018

Study Completion

May 1, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)