- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770847
Arterial Stiffness in Chronic Kidney Disease
November 14, 2017 updated by: University of Edinburgh
Diurnal Variations in Arterial Stiffness in Patients With Chronic Kidney Disease and Healthy Age Matched Controls
Diurnal variations in the cardiovascular system apparent in healthy individuals, are different in chronic kidney disease patients.
Therefore, diurnal variations in arterial stiffness may also differ in chronic kidney disease patients.
This study aims to identify and evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and compare them to those in age matched healthy controls.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edinburgh, United Kingdom, EH4 2XU
- Clinical Research Centre, 2nd Floor Western General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Potential patients will be identified from renal clinics at the Royal Infirmary and Western General Hospital. Suitable participants will initially be identified by a member of the direct healthcare team.
Healthy volunteers will be indentified through the Clinical Research Centre community database and poster advertising at the University of Edinburgh.
Description
Inclusion Criteria:
- Systolic blood pressure <160 whether or not on antihypertensive medication
- diastolic blood pressure <100mmHg whether or not on antihypertensive medication
- Chronic kidney disease stage 2-5
Exclusion Criteria:
- Systolic blood pressure ≥160mmHg
- Diastolic blood pressure ≥100mmhg
- Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy controls
Healthy age matched controls
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Chronic kidney diease
Chronic kidney disease patients stage 2-4
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diurnal variations in arterial stiffness
Time Frame: Over one 26 hour period arterial stiffness measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am
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The principal objective of this study is to evaluate whether diurnal variations in arterial stiffness are blunted in chronic kidney disease compared to healthy age matched controls
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Over one 26 hour period arterial stiffness measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diurnal variations in aortic and brachial blood pressure
Time Frame: Over one 26 hour period blood pressure measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am
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Secondary objective of this study is to evaluate whether diurnal variations in aortic and brachial blood pressure are blunted in chronic kidney disease compared to healthy age matched controls
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Over one 26 hour period blood pressure measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am
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Relationship between changes in blood pressure and arterial stiffness
Time Frame: Over one 26 hour period
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Secondary objective of this study is to evaluate whether diurnal variations in arterial stiffness are dependent on changes in blood pressure in both chronic kidney disease patients and age matched controls.
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Over one 26 hour period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David J Webb, MB BS MD DSc FRCP FRSE FMedSci, University of Edinburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 28, 2012
First Submitted That Met QC Criteria
January 15, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 14, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12\SS\0088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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