Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Universitaire Ziekenhuizen KU Leuven1,000 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,000

Conditions

Kidney Diseases Diastolic Heart Failure Small Vessel Disease Glaucoma

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitaire Ziekenhuizen UZ/KU Leuven

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

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

Time frame: 3 years

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

Physiological behaviour of retinal vasculature under cardiovascular stress.

Time frame: 3 years

Histopathological correlates in dermal microvasculature

Time frame: 3 years

Central Contacts

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

Data from ClinicalTrials.gov

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