Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Not Applicable

Recruiting

• Conditions: Small Vessel Disease; Diastolic Heart Failure; Kidney Diseases; Glaucoma

• Registration Number: NCT06485128
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2021-07-06
• Status Verified: 2023-09
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitaire Ziekenhuizen UZ/KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium