Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Universitaire Ziekenhuizen KU Leuven1 site in 1 country1,000 target enrollmentJuly 6, 2021

ConditionsKidney Diseases Diastolic Heart Failure Small Vessel Disease Glaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Diseases
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 1000
Locations: 1
Primary Endpoint: Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2021

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Time Frame: 3 years

Secondary Outcomes

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(3 years)
Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.(3 years)
Histopathological correlates in dermal microvasculature(3 years)
Physiological behaviour of retinal vasculature under cardiovascular stress.(3 years)