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Health research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Health

Hypertension

Chronic Kidney Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Treated hypertensionPatients on treatment for hypertension

CKD-ESRD

Healthy individualsHealthy volunteers

CKD

HypertensionUntreated

Study Status

Recruiting

Start Date: May 2014

Completed Date: September 2020

Phase:

Type: Observational

Design:

Primary Outcome:

Secondary Outcome: Neuro-retinal metrics

Study sponsors, principal investigator, and references

Principal Investigator: Neeraj Dhaun, MD PhD

Lead Sponsor: University of Edinburgh

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02132741

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