Exploring retinal blood vessel function in patients with various diseases
Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
This study tests how well the tiny blood vessels in the eyes work in people with chronic kidney disease, heart failure, small vessel disease, and glaucoma, compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06485128 on ClinicalTrials.gov |
What this trial studies
This interventional cohort study investigates the retinal vascular function in patients with chronic kidney disease, heart failure, small vessel disease, and glaucoma, using advanced imaging techniques such as optical coherence tomography angiography and dynamic vessel analysis. The study also includes age-matched healthy controls for comparative analysis. Additionally, plasma and skin samples will be collected for proteomic and transcriptomic studies to further understand the underlying mechanisms of microvascular involvement in these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults with glaucoma, chronic kidney disease, heart failure with preserved ejection fraction, small vessel disease, or healthy individuals without relevant pathology.
Not a fit: Patients with diabetes or a history of retinal neovascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with ocular and systemic diseases linked to endothelial dysfunction.
How similar studies have performed: While the approach of investigating retinal vascular function in relation to systemic diseases is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams-Brabant
- Universitaire Ziekenhuizen UZ/KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Ingeborg Stalmans, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Jan Van Eijgen, MD
- Email: jan.1.vaneijgen@uzleuven.be
- Phone: +32 16 34 56 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.