Arterial Stiffness in Chronic Kidney Disease

This study is currently recruiting participants.
Verified March 2013 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01770847
First received: November 28, 2012
Last updated: March 4, 2013
Last verified: March 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated 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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770847

Contacts
Contact: David J Webb, MB BS MD DSc FRCP FRSE FMedSci 0131 242 9216 D.J.Webb@ed.ac.uk

Locations
United Kingdom
Clinical Research Centre, 2nd Floor Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: David J Webb, MB BS MD DSc FRCP FRSE FMedSci    0131 242 9216    d.j.webb@ed.ac.uk   
Principal Investigator: David J Webb, MB BS MD DSc FRCP FRSE FMedSci         
Sub-Investigator: Rebecca C Moorhouse, MSc         
Sub-Investigator: Iain Drummond, MBChB MRCP (UK)         
Sub-Investigator: Ewan Kennedy, BSc (hons)         
Sub-Investigator: Kayleigh Brown, BMedSci (hons)         
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: David J Webb, MB BS MD DSc FRCP FRSE FMedSci University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01770847     History of Changes
Other Study ID Numbers: 12\SS\0088
Study First Received: November 28, 2012
Last Updated: March 4, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014