Chronic Kidney DiseaseNCT01770847
Arterial Stiffness in Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Systolic blood pressure ≥160mmHg
- Diastolic blood pressure ≥100mmhg
- Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Centre, 2nd Floor Western General Hospital
Edinburgh, EH4 2XU
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy age matched controls | |
| Chronic kidney diease | Chronic kidney disease patients stage 2-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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.
Measured: Over one 26 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Webb, MB BS MD DSc FRCP FRSE FMedSci, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770847
- Sponsor's protocol ID
- 12\SS\0088
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2012
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24890823
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variations in Arterial Stiffness in Patients With Chronic Kidney Disease and Healthy Age Matched Controls
- ClinicalTrials.gov ID
- NCT01770847
- Acronym / sponsor ID
- 12\SS\0088
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Healthy age matched controls |
| Chronic kidney diease | – | –Chronic kidney disease patients stage 2-4 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Systolic blood pressure ≥160mmHg
- Diastolic blood pressure ≥100mmhg
- Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Relationship between changes in blood pressure and arterial stiffness
Time frame: Over one 26 hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 24890823Dhaun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Webb, MB BS MD DSc FRCP FRSE FMedSci principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.