Optical Coherence Tomography And NEphropathy: The OCTANE Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Edinburgh
About this trial
Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female
Age 18-80
Body mass index ≤35
For those with hypertension: BP ≥140/90 or on treatment for hypertension
Disqualifiers
Subject is below the age of legal consent, or is mentally or legally incapacitated
The subject has donated blood (450 ml) within the last 4 weeks
Past or present drug or alcohol abuse including intravenous drug abuse at any time
Participation in another clinical trial within 1 month
Trial population
Healthy volunteers will be recruited from a research database. CKD and patients with hypertension will be recruited from these respective clinics in secondary care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 5 trial groupsGroup A: Treated hypertension
Group B: CKD-ESRD
Group C: Healthy individuals
Group D: Chronic kidney disease
Group E: Hypertension
Trial outcomes
Primary outcomes
1
Choroidal & retinal morphology
A composite measures outcome including: 1. Sub-foveal choroidal thickness 2. Choroidal volume 3. Retinal vasculature morphology and optimality measurements (arteriolar thickness, branching coefficient and branching angle; fractal dimension, and venular tortuosity.)
Time frame
2 weeksSecondary outcomes
1
Neuro-retinal metrics
A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov