NCT01770847

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

November 28, 2012

Last Update Submit

November 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diurnal variations in arterial stiffness

    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

    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

Secondary Outcomes (2)

  • Diurnal variations in aortic and brachial blood pressure

    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

  • Relationship between changes in blood pressure and arterial stiffness

    Over one 26 hour period

Study Arms (2)

Healthy controls

Healthy age matched controls

Chronic kidney diease

Chronic kidney disease patients stage 2-4

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Systolic blood pressure ≥160mmHg
  • Diastolic blood pressure ≥100mmhg
  • Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, 2nd Floor Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (1)

  • Dhaun N, Moorhouse R, MacIntyre IM, Melville V, Oosthuyzen W, Kimmitt RA, Brown KE, Kennedy ED, Goddard J, Webb DJ. Diurnal variation in blood pressure and arterial stiffness in chronic kidney disease: the role of endothelin-1. Hypertension. 2014 Aug;64(2):296-304. doi: 10.1161/HYPERTENSIONAHA.114.03533.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David J Webb, MB BS MD DSc FRCP FRSE FMedSci

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

January 18, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations