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Status unknownNCT06485128Updated Jul 3, 2024

Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

An interventional study of Optical coherence tomography(-angiography) OCT(A) and Fundus pictures in Kidney Diseases, Diastolic Heart Failure and Small Vessel Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jul 2021, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Kidney Diseases
  • Diastolic Heart Failure
  • Small Vessel Disease
  • Glaucoma
03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Personal medical history of retinal neovascularization.
  • Unable or unwilling to give consent
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Other
    Chronic kidney disease

    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

  • Other
    Diastolic heart failure

    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

  • Other
    Neuronal small vessel disease

    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

  • Other
    Glaucoma

    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

  • Other
    Healthy patients

    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

Interventions

  • Diagnostic testOptical coherence tomography(-angiography) OCT(A)

    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.

  • Diagnostic testFundus pictures

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

  • Diagnostic testDVA 3.0

    IMEDOS GmbH

  • Diagnostic testHyperspectral retinal images

    Ximea SNm4x4 hyperspectral snapshot camera

  • Diagnostic testSphygmoCor

    Sphygmocor Excell

  • Diagnostic testSphygmomanometer

    For the measurement of the blood pressure.

  • Diagnostic testBlood sample

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

  • Diagnostic testSkin biopsy

    Spatial proteomics and transcriptomics for endothelial function.

  • Diagnostic testNeuropsychological examination

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 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

    Time frame: 3 years

  3. Physiological behaviour of retinal vasculature under cardiovascular stress.

    Time frame: 3 years

  4. Histopathological correlates in dermal microvasculature

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Universitaire Ziekenhuizen UZ/KU Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
    • Sarah Spileers, SC · Contact · oogziekten.glaucoomstudies@uzleuven.be · +32 16 34 03 91
    • Amaryllis Van Craenenbroeck, MD, PhD · Sub investigator
    • Jan Van Eijgen, MD · Sub investigator
    • Véronique Cornelissen, MD, PHD · Sub investigator
    • Elisabeth Jones, PhD · Sub investigator
    • Mathieu Vandenbulcke, MD, PHD · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Dec 2024, 41 months after the start.

Of 510 non-industry interventional studies with no phase under Kidney Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 41 months is above that.

Counting every sponsor, half of 555 studies reached it within 23 months; a quarter within 10 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2023
First posted
Jul 3, 2024
StartActual
Jul 6, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06485128
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jul 3, 2024
Start date
Jul 6, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 3, 2024

Study contacts

Jan Van Eijgen, MD
Contact
jan.1.vaneijgen@uzleuven.be
+32 16 34 56 28
Sarah Spileers, SC
Contact
oogziekten.glaucoomstudies@uzleuven.be
+32 16 34 03 91
Ingeborg Stalmans, MD, PhD
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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