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Arterial Stiffness in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770847
First Posted: January 18, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Edinburgh
  Purpose
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.

Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Diurnal Variations in Arterial Stiffness in Patients With Chronic Kidney Disease and Healthy Age Matched Controls

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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 ]
    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


Secondary Outcome Measures:
  • 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 ]
    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

  • Relationship between changes in blood pressure and arterial stiffness [ Time Frame: Over one 26 hour period ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy controls
Healthy age matched controls
Chronic kidney diease
Chronic kidney disease patients stage 2-4

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
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): NCT01770847


Locations
United Kingdom
Clinical Research Centre, 2nd Floor Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: David J Webb, MB BS MD DSc FRCP FRSE FMedSci University of Edinburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01770847     History of Changes
Other Study ID Numbers: 12\SS\0088
First Submitted: November 28, 2012
First Posted: January 18, 2013
Last Update Posted: November 17, 2017
Last Verified: November 2017

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