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Optical Coherence Tomography (OCT) in Hypertension & Chronic Kidney Disease (CKD)

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ClinicalTrials.gov Identifier: NCT02132741
Recruitment Status : Recruiting
First Posted : May 7, 2014
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease
Health Hypertension Chronic Kidney Disease

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Treated hypertension
Patients on treatment for hypertension
Pre- & post haemodialysis
Healthy individuals
Healthy volunteers
Pre-dialysis CKD & those with a functional renal transplant

Primary Outcome Measures :
  1. Choroidal & retinal morphology [ Time Frame: 2 weeks ]

    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.)

Secondary Outcome Measures :
  1. Neuro-retinal metrics [ Time Frame: 2 weeks ]
    A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132741

Contact: Neeraj Dhaun, MD PhD 01312429215 bean.dhaun@ed.ac.uk
Contact: David Webb 01312429215 d.j.webb@ed.ac.uk

United Kingdom
University of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH164TJ
Principal Investigator: Neeraj Dhaun, MD PhD         
Sponsors and Collaborators
University of Edinburgh
Principal Investigator: Neeraj Dhaun, MD PhD University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02132741     History of Changes
Other Study ID Numbers: 14/SS/0069
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Edinburgh:
OCT; hypertension; CKD

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency