Optical Coherence Tomography And NEphropathy: The OCTANE Study

NCT ID: NCT02132741

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-16

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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This project is an exploratory study, using enhanced depth imaging with the new SPECTRALIS OCT, designed to examine choroidal and microvascular retinal structure in patients with hypertension, chronic kidney disease (CKD), and in age and sex matched healthy controls. The study is non-invasive and takes only a few seconds to acquire these complex images. The Centre, where the images will be captured and where image analysis systems are located, is on the Royal Infirmary of Edinburgh (RIE) site close to the RIE outpatient clinics, making recruitment easy.

Conditions

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Health Hypertension Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated hypertension

Patients on treatment for hypertension

No interventions assigned to this group

CKD-ESRD

Pre- \& post haemodialysis

No interventions assigned to this group

Healthy individuals

Healthy volunteers

No interventions assigned to this group

Chronic kidney disease

Pre-dialysis CKD \& those with a functional renal transplant

No interventions assigned to this group

Hypertension

Untreated

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age 18-80
* Body mass index ≤35
* For those with hypertension: BP ≥140/90 or on treatment for hypertension
* For those with CKD: CKD as defined by the Kidney Diseases Quality Initiative guidelines

Exclusion Criteria

* 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
* Considered to be at high risk of HIV or hepatitis B
* Patients with known eye disease, or previous eye surgery, or refractive error greater than +/- 6 dioptres.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neeraj Dhaun, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Neeraj Dhaun, MD PhD

Role: CONTACT

01312429215

David Webb

Role: CONTACT

01312429215

References

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Balmforth C, van Bragt JJ, Ruijs T, Cameron JR, Kimmitt R, Moorhouse R, Czopek A, Hu MK, Gallacher PJ, Dear JW, Borooah S, MacIntyre IM, Pearson TM, Willox L, Talwar D, Tafflet M, Roubeix C, Sennlaub F, Chandran S, Dhillon B, Webb DJ, Dhaun N. Chorioretinal thinning in chronic kidney disease links to inflammation and endothelial dysfunction. JCI Insight. 2016 Dec 8;1(20):e89173. doi: 10.1172/jci.insight.89173.

Reference Type DERIVED
PMID: 27942587 (View on PubMed)

Other Identifiers

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14/SS/0069

Identifier Type: -

Identifier Source: org_study_id

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