AzTrials
AzTrials

Kidney DiseasesNCT06485128

Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

A study testing Optical coherence tomography(-angiography) OCT(A), Fundus pictures and DVA 3.0 in people with Kidney Diseases and Diastolic Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Optical coherence tomography(-angiography) OCT(A), Fundus pictures and DVA 3.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteBelgium
Study dates
6 Jul 2021to 31 Dec 2024
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patients with a confirmed or suspect diagnosis of glaucoma based on intra-ocular eye pressure, visual field defect and structural optic nerve changes, regardless their age.
  • Adult patients with chronic kidney disease regardless their age.
  • Adult patients with heart failure with preserved ejection fraction (HFpEF), regardless their age: symptomatic heart failure with Left Ventricle Ejection Fraction > 50% AND BNP > 35 pg/ml (or NT-proBNP>125 pg/ml) OR signs of diastolic dysfunction according to the European Society of Cardiology guidelines 2016
  • Adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age.
  • People without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age
  • Capable and willing to participate (informed consent)

Who cannot join

  • Diabetes
  • Personal medical history of retinal neovascularization.
  • Unable or unwilling to give consent

Trial locations and contacts

1 site in 1 country.

Jan Van Eijgen, MD contact

+32 16 34 56 28

jan.1.vaneijgen@uzleuven.be

Sarah Spileers, SC contact

+32 16 34 03 91

oogziekten.glaucoomstudies@uzleuven.be

Belgium1 site, 1 recruiting

  • Universitaire Ziekenhuizen UZ/KU Leuven

    Leuven, Vlaams-Brabant, 3000

    Sarah Spileers, SC, +32 16 34 03 91, oogziekten.glaucoomstudies@uzleuven.be

    Amaryllis Van Craenenbroeck, MD, PhD

    Recruiting

Other trials in Belgium

About this study

To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

Read the detailed description

In this interventional cohort study, the investigators aim to evaluate retinal vascular function as assessed by optical coherence tomography angiography, fundus photography and dynamic vessel analysis in patients who share microvascular involvement of their pathology (e.g. chronic kidney disease, cardiac decompensation, neuronal small vessel disease and glaucoma) and age-matched healthy controls. Plasm and skin samples for comparative proteomics and transcriptomics are also taken.

Being tested
Optical coherence tomography(-angiography) OCT(A), Fundus pictures, DVA 3.0, Hyperspectral retinal images, SphygmoCor
Medical subject headings
Kidney Diseases, Heart Failure, Diastolic, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical coherence tomography(-angiography) OCT(A)Diagnostic test

    OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.

  • Fundus picturesDiagnostic test

    Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)

  • DVA 3.0Diagnostic test

    IMEDOS GmbH

  • Hyperspectral retinal imagesDiagnostic test

    Ximea SNm4x4 hyperspectral snapshot camera

  • SphygmoCorDiagnostic test

    Sphygmocor Excell

  • SphygmomanometerDiagnostic test

    For the measurement of the blood pressure.

  • Blood sampleDiagnostic test

    For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).

  • Skin biopsyDiagnostic test

    Spatial proteomics and transcriptomics for endothelial function.

  • Neuropsychological examinationDiagnostic test

    Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS

Study groups in NCT06485128
Study groupRoleWhat they receive
Chronic kidney diseaseOtherNot described
Receives: Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Fundus pictures; Diagnostic Test: DVA 3.0; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: SphygmoCor; Diagnostic Test: Sphygmomanometer; Diagnostic Test: Blood sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Neuropsychological examination
Diastolic heart failureOtherNot described
Receives: Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Fundus pictures; Diagnostic Test: DVA 3.0; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: SphygmoCor; Diagnostic Test: Sphygmomanometer; Diagnostic Test: Blood sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Neuropsychological examination
Neuronal small vessel diseaseOtherNot described
Receives: Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Fundus pictures; Diagnostic Test: DVA 3.0; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: SphygmoCor; Diagnostic Test: Sphygmomanometer; Diagnostic Test: Blood sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Neuropsychological examination
GlaucomaOtherNot described
Receives: Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Fundus pictures; Diagnostic Test: DVA 3.0; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: SphygmoCor; Diagnostic Test: Sphygmomanometer; Diagnostic Test: Blood sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Neuropsychological examination
Healthy patientsOtherNot described
Receives: Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Fundus pictures; Diagnostic Test: DVA 3.0; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: SphygmoCor; Diagnostic Test: Sphygmomanometer; Diagnostic Test: Blood sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Neuropsychological examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.

    Measured: 3 years

Secondary outcomes (4)

  1. Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.

    Measured: 3 years

  2. The association between these parameters and (1) the presence of risk factors for cardiovascular disease (including biomarkers) and (2) risk factors for disease progression and (3) neuropsychological functioning

    Measured: 3 years

  3. Physiological behaviour of retinal vasculature under cardiovascular stress.

    Measured: 3 years

  4. Histopathological correlates in dermal microvasculature

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start6 Jul 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485128
Sponsor's protocol ID
S63649
Status last verified
Sep 2023
First submitted
5 Oct 2023
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Optical coherence tomography(-angiography) OCT(A), Fundus pictures and DVA 3.0 in people with Kidney Diseases and Diastolic Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Van Eijgen, MD (+32 16 34 56 28, jan.1.vaneijgen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06485128.

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 3 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in