Health TrialsbyHealthPanel

Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome

ConditionsTurner SyndromeCardiovascular DiseasesLymphedemaInflammation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorUniversity of Aarhus

About this trial

100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.

The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Turner Syndrome

Disqualifiers

pregnancy

contraindications for MRI

Trial population

Danish women.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention other than obtaining biopsies

    Other intervention

    Skin, fat, and muscle biopsies will be obtained

  • Indocyanine green (ICG)

    Drug

    Indocyanine green will be injected to evaluate the lymphatic system.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Turner Syndrome2 interventions
Group B: Female controls2 interventions

Trial outcomes

Primary outcomes

1

Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography.

Lymphedema will be graded in a total score according to the International Society of Lymphology. The stages are: Stage 0: Subclinical lymphedema. • Stage 1: Early, reversible pitting edema. Stage 2: Irreversible lymphedema. Stage 3: End-stage lymphedema.

Time frame
3 year
2

Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation.

Time frame
3 years
3

Heat maps of the distribution of wall shear stress in the aorta

Using 4D-flow analyses heat maps of the aorta will be made to illustrate the distribution of wall shear stress.

Time frame
3 years

Secondary outcomes

1

MRI evaluation and description of vascular abnormalities in Turner Syndrome

Aortic dimensions

Time frame
3 years
2

Cardiac MRI to evaluate function

Diastolic and systolic function of the left ventricle

Time frame
3 years
3

Cardiac MRI to evaluate fibrosis of the myocardium

Estimation of myocardial fibrosis

Time frame
3 years
4

Mapping DNA-methylations patterns in multiple tissues

Mapping DNA-methylation patterns in muscle, skin, fat, blood and urine

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Source ClinicalTrials.gov
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