Clinical trial NCT06485128: Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
Official title: Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Diseases
Diastolic Heart Failure
Small Vessel Disease
Glaucoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

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

Primary outcomes:
measure: Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
timeFrame: 3 years
Secondary outcomes:
measure: Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Physiological behaviour of retinal vasculature under cardiovascular stress.
timeFrame: 3 years
measure: Histopathological correlates in dermal microvasculature
timeFrame: 3 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen UZ/KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ingeborg Stalmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: