Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Not Applicable

Recruiting

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

• 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

Arm && Interventions

Group	Intervention	Description
Neuronal small vessel disease	DVA 3.0	-
Healthy patients	DVA 3.0	-
Glaucoma	Sphygmomanometer	-
Healthy patients	SphygmoCor	-
Neuronal small vessel disease	Sphygmomanometer	-
Glaucoma	Skin biopsy	-
Healthy patients	Sphygmomanometer	-
Neuronal small vessel disease	Skin biopsy	-
Glaucoma	SphygmoCor	-
Chronic kidney disease	Fundus pictures	-
Healthy patients	Fundus pictures	-
Chronic kidney disease	Optical coherence tomography(-angiography) OCT(A)	-
Chronic kidney disease	Skin biopsy	-
Diastolic heart failure	Optical coherence tomography(-angiography) OCT(A)	-
Diastolic heart failure	Blood sample	-
Diastolic heart failure	Skin biopsy	-
Neuronal small vessel disease	Hyperspectral retinal images	-
Neuronal small vessel disease	SphygmoCor	-
Chronic kidney disease	DVA 3.0	-
Chronic kidney disease	Hyperspectral retinal images	-
Chronic kidney disease	Neuropsychological examination	-
Chronic kidney disease	SphygmoCor	-
Chronic kidney disease	Sphygmomanometer	-
Diastolic heart failure	Fundus pictures	-
Diastolic heart failure	Hyperspectral retinal images	-
Diastolic heart failure	Sphygmomanometer	-
Diastolic heart failure	Neuropsychological examination	-
Chronic kidney disease	Blood sample	-
Diastolic heart failure	SphygmoCor	-
Neuronal small vessel disease	Fundus pictures	-
Neuronal small vessel disease	Blood sample	-
Diastolic heart failure	DVA 3.0	-
Neuronal small vessel disease	Optical coherence tomography(-angiography) OCT(A)	-
Neuronal small vessel disease	Neuropsychological examination	-
Glaucoma	DVA 3.0	-
Glaucoma	Blood sample	-
Healthy patients	Blood sample	-
Glaucoma	Fundus pictures	-
Glaucoma	Neuropsychological examination	-
Glaucoma	Optical coherence tomography(-angiography) OCT(A)	-
Glaucoma	Hyperspectral retinal images	-
Healthy patients	Optical coherence tomography(-angiography) OCT(A)	-
Healthy patients	Hyperspectral retinal images	-
Healthy patients	Skin biopsy	-
Healthy patients	Neuropsychological examination	-

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
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

Trial Locations

Locations (1)

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