Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

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

Treatments: Diagnostic Test: SphygmoCor; Diagnostic Test: Hyperspectral retinal images; Diagnostic Test: Fundus pictures; Diagnostic Test: Neuropsychological examination; Diagnostic Test: Skin biopsy; Diagnostic Test: Optical coherence tomography(-angiography) OCT(A); Diagnostic Test: Blood sample; Diagnostic Test: DVA 3.0; Diagnostic Test: Sphygmomanometer

Study type: Interventional

Funder types: Other

Identifiers

NCT06485128

S63649

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 5 patient groups

Chronic kidney disease

Other group

Treatment:

Diagnostic Test: Sphygmomanometer

Diagnostic Test: DVA 3.0

Diagnostic Test: Blood sample

Diagnostic Test: Skin biopsy

Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)

Diagnostic Test: Neuropsychological examination

Diagnostic Test: Fundus pictures

Diagnostic Test: Hyperspectral retinal images

Diagnostic Test: SphygmoCor

Diastolic heart failure

Other group

Treatment:

Diagnostic Test: Sphygmomanometer

Diagnostic Test: DVA 3.0

Diagnostic Test: Blood sample

Diagnostic Test: Skin biopsy

Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)

Diagnostic Test: Neuropsychological examination

Diagnostic Test: Fundus pictures

Diagnostic Test: Hyperspectral retinal images

Diagnostic Test: SphygmoCor

Neuronal small vessel disease

Other group

Treatment:

Diagnostic Test: Sphygmomanometer

Diagnostic Test: DVA 3.0

Diagnostic Test: Blood sample

Diagnostic Test: Skin biopsy

Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)

Diagnostic Test: Neuropsychological examination

Diagnostic Test: Fundus pictures

Diagnostic Test: Hyperspectral retinal images

Diagnostic Test: SphygmoCor

Glaucoma

Other group

Treatment:

Diagnostic Test: Sphygmomanometer

Diagnostic Test: DVA 3.0

Diagnostic Test: Blood sample

Diagnostic Test: Skin biopsy

Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)

Diagnostic Test: Neuropsychological examination

Diagnostic Test: Fundus pictures

Diagnostic Test: Hyperspectral retinal images

Diagnostic Test: SphygmoCor

Healthy patients

Other group

Treatment:

Diagnostic Test: Sphygmomanometer

Diagnostic Test: DVA 3.0

Diagnostic Test: Blood sample

Diagnostic Test: Skin biopsy

Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)

Diagnostic Test: Neuropsychological examination

Diagnostic Test: Fundus pictures

Diagnostic Test: Hyperspectral retinal images

Diagnostic Test: SphygmoCor