Optical Coherence Tomography And NEphropathy: The OCTANE Study

NCT02132741 | Recruiting

• 1 other identifier: 14/SS/0069
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health; Hypertension; Chronic Kidney Disease

Keywords

OCT; hypertension; CKD

Outcome Measures

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.)

  2 weeks

Secondary Outcomes (1)

• Neuro-retinal metrics

  2 weeks

Study Arms (5)

Treated hypertension

Patients on treatment for hypertension

CKD-ESRD

Pre- \& post haemodialysis

Healthy individuals

Healthy volunteers

Chronic kidney disease

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

Hypertension

Untreated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH164TJ, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 27942587 DERIVED

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic; Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Neeraj Dhaun, MD PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraj Dhaun, MD PhD

CONTACT

01312429215; bean.dhaun@ed.ac.uk

David Webb

CONTACT

01312429215; d.j.webb@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 7, 2014
• Study Start: May 16, 2014
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2024-06

Locations

GB (1)