Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

NCT06485128 | Unknown

• 1 other identifier: S63649
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.

  3 years

Secondary Outcomes (4)

• Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.

  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

• Physiological behaviour of retinal vasculature under cardiovascular stress.

  3 years

• Histopathological correlates in dermal microvasculature

  3 years

Study Arms (5)

Chronic kidney disease

OTHER

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

Diastolic heart failure

OTHER

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

Neuronal small vessel disease

OTHER

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

Glaucoma

OTHER

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

Healthy patients

OTHER

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

Interventions

Optical coherence tomography(-angiography) OCT(A) DIAGNOSTIC_TEST

OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Fundus pictures DIAGNOSTIC_TEST

Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

DVA 3.0 DIAGNOSTIC_TEST

IMEDOS GmbH

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Hyperspectral retinal images DIAGNOSTIC_TEST

Ximea SNm4x4 hyperspectral snapshot camera

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

SphygmoCor DIAGNOSTIC_TEST

Sphygmocor Excell

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Sphygmomanometer DIAGNOSTIC_TEST

For the measurement of the blood pressure.

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Blood sample DIAGNOSTIC_TEST

For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Skin biopsy DIAGNOSTIC_TEST

Spatial proteomics and transcriptomics for endothelial function.

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Neuropsychological examination DIAGNOSTIC_TEST

Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS

Chronic kidney disease; Diastolic heart failure; Glaucoma; Healthy patients; Neuronal small vessel disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen UZ/KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Heart Failure, Diastolic; Glaucoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ingeborg Stalmans, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Van Eijgen, MD

CONTACT

+32 16 34 56 28; jan.1.vaneijgen@uzleuven.be

Sarah Spileers, SC

CONTACT

+32 16 34 03 91; oogziekten.glaucoomstudies@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: July 3, 2024
• Study Start: July 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2023-09

Locations

BE (1)