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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02132741
First received: April 29, 2014
Last updated: May 2, 2014
Last verified: April 2014
  Purpose

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
Health
Hypertension
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASSESSMENT OF RETINAL VASCULATURE USING OPTICAL COHERENCE TOMOGRAPHY IN HEALTH, HYPERTENSION & CHRONIC KIDNEY DISEASE

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Choroidal & retinal morphology [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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:
  • Neuro-retinal metrics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)


Estimated Enrollment: 150
Study Start Date: May 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treated hypertension
Patients on treatment for hypertension
CKD-ESRD
Pre- & post haemodialysis
Healthy individuals
Healthy volunteers
CKD
Pre-dialysis CKD
Hypertension
Untreated

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132741

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

Locations
United Kingdom
University of Edinburgh Not yet recruiting
Edinburgh, Midlothian, United Kingdom, EH164TJ
Principal Investigator: Neeraj Dhaun, MD PhD         
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: Neeraj Dhaun, MD PhD University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02132741     History of Changes
Other Study ID Numbers: 14/SS/0069
Study First Received: April 29, 2014
Last Updated: May 2, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014