End-Stage Renal DiseaseNCT02196610
Feasibility Study of Arterial Stiffness in Hemodialysis Patients
An observational study of End-Stage Renal Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
People with kidney failure have a higher chance of getting disease in the blood vessels and this result in a decreased elasticity of the arteries of their body which make them very stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk of stroke and heart disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Applanation tonometry
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Mar 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HEALTHY SUBJECTS: 20 healthy staff volunteers. ESRD group: 20 patients with stage 5 CKD (estimated GFR <15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH).
Who may be able to join
- Age: >18 years
- Able to provide informed consent
- Adult patient (age: >18 years) with ESRD (estimated glomerular filtration rate: <15 ml/min/m2)
- Receiving hemodialysis treatments, with no expected renal recovery
- Having received regular in-Centre Hemodialysis at TOH for at least the past 3 weeks
- Able to provide informed consent.
Who cannot join
- History of cardiovascular disease and/or hypertension (blood pressure >140/90 mm Hg)
- History of diabetes mellitus
- History of liver or kidney disease, cancer and/or any lymphoproliferative disease
- Currently receiving medication for any medical condition or illness
- Body Mass Index (BMI) ≥ 30 Kg/m2
- Pregnancy
Show all 20Show fewer
- Any condition that limits functional ability and precludes participation
- Current smoker (>15 cigarettes per day) in the last 6 months.
- Former smoker (> 20 cigarettes per day) who stopped smoking < 2 years ago.
- Excessive alcohol intake (men >14 drinks per week; women: > 9 drinks per week).
- Psychoactive or performance-enhancing drug abuse.
- END-STAGE RENAL DISEASE (ESRD) GROUP
- Atrial fibrillation (as it frequently results in transient or persistent rapid heart rates and these changes overestimate aortic stiffness).
- Active cancer or history of cancer in the past 5 years.
- Pregnancy
- Any condition that limit the patient's ambulatory ability and preclude participation on this basis
- Mechanical, bioprosthetic heart valves or mechanical assisting devices (these conditions may change myocardial stiffness and the volumetric properties of the left ventricle leading to diastolic dysfunction and these physiologic changes may modify the waveforms of the cf- APWV).
- Pre-dialysis systolic blood pressure ≥ 200 mm Hg recorded in the last 6 dialysis treatments (2 weeks).
- Inability to measure blood pressure in at least one arm.
- Current smoker (>15 cigarettes per day) in the last 6 months [Daily cigarette consumption (>15 cigarettes per day) adjusted by age, education level and other confounders has been found to be independently associated with the risk of hypertension].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Stiffness in Healthy Subjects and Patients With End-Stage- Renal Disease: A Feasibility Study
People with kidney failure have a higher chance of getting disease in the blood vessels and this result in a decreased elasticity of the arteries of their body which make them very stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a method called "applanation tonometry", which measures the "pulse wave velocity" of major blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to determine if we can measure arterial stiffness reliably and accurately using this method in healthy people and in people with kidney failure receiving hemodialysis treatments at our centre. Also, we would like to know how stiff these arteries in healthy people are. If we demonstrate that the method is reliable and accurate in these 2 groups of participants at our centre, a future larger study is planned to determine if we can use measures of arterial stiffness to evaluate the risk of stroke and heart disease in people with kidney failure receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside Campus.
Read the detailed description
Background:
Cardiovascular (CV) disease is a major cause of morbidity and mortality in patients with end-stage renal disease (ESRD). Arterial stiffness measured by pulse-wave velocity (PWV) has been identified as an independent predictor of fatal CV events in these patients. Our long-term goal is to study the impact of interventions that decrease progressive arterial stiffness on CV mortality in ESRD patients. Thus, we postulate that measurements of PWV during these interventions will predict CV outcome. Before studying this relationship, establishing the feasibility of PWV measurements at our centre is necessary.
Objectives:
- To demonstrate the reliability and accuracy of arterial PWV measurements in healthy subjects and patients with ESRD at our centre, ii) To assess subject satisfaction and level of discomfort associated with the testing procedure, iii) To characterize normative values for the PWV in our two subject groups, and iv) To determine the feasibility of recruitment of patients with ESRD, as a pre-requisite for a larger trial focused on CV outcomes.
Methods:
PWV will be measured consecutively by 2 research assistants in: a) a group of 20 healthy subjects; and b) a group of 20 patients with ESRD on chronic hemodialysis at The Ottawa Hospital. Two consecutive sets of PWV measurements with a time-interval of 1 week (± 2 days) will be obtained in the healthy and ESRD groups (pre-hemodialysis, between 2 consecutive mid-week hemodialysis sessions). To determine the impact of hemodialysis on PWV measures, in a sub-group of 10 ESRD subjects measurements will be taken before and after hemodialysis. The order of testing by the 2 assistants will be randomized.
- Conditions
- End-Stage Renal Disease
- Being tested
- Applanation tonometry
- Keywords
- End-Stage Renal Disease,, arterial or vascular stiffness,, hemodialysis,, Pulse wave velocity, Renal insufficiency,, tonometry
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applanation tonometryOther
Also called carotid-femoral Pulse wave velocity (c-f-PWV)
Two consecutive sets of carotid-femoral Pulse Wave Velocity (PWV) measurements by Applanation tonometry with a time-interval of 1 week will be obtained (1 week ± 2 days). Two research assistants will each perform a carotid-femoral-PWV measurement at each time point with the testing order randomized.
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY SUBJECTS group | A group of 20 healthy staff volunteers identified from the Division of Nephrology, Dept. of Medicine and the Kidney Research Centre at the Ottawa Hospital Research Institute will be invited to participate. Measurements of arterial stiffness will be performed by Applanation tonometry. Healthy status will be defined by a self-reporting questionnaire obtained over the phone prior to enrolment and 2 subsequent non-invasive measurements of arterial blood pressure (BP) prior to testing. Subjects will be included if diastolic BP is ≤ 90 mm Hg and systolic BP ≤ 140 mm Hg on 2 consecutive measurements. Receives: Other: Applanation tonometry | |
| END-STAGE RENAL DISEASE (ESRD) group | A group of 20 patients with stage 5 Chronic Kidney Disease (estimated glomerular filtration rate <15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH) will be invited to participate. Measurements of arterial stiffness will be performed in this group by Applanation tonometry. Receives: Other: Applanation tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of carotid-femoral Pulse Wave Velocity measurements
We will estimate the Pulse Wave Velocity differences and the intra-class correlation coefficient (ICC) between the 2 examinations (test-retest) recorded in the same subject 1 week apart. We will also estimate the examiner's reliability by the inter-rater agreement through the ICC and limits of agreement.
Measured: 1 week
Secondary outcomes (3)
Accuracy of the carotid-femoral Pulse Wave Velocity measurements
This will be estimated by calculating the mean, standard deviation and 95% confidence interval of the Pulse Wave Velocity differences between our healthy group and the age-adjusted mean values from a historical healthy control group
Measured: 1 week
Subject satisfaction and procedure discomfort
This will be accomplished by surveying subjects at the end of the testing procedure using a Likert-type questionnaire
Measured: 1 week
Recruitment Efficacy
We will assess the proportion of patients with End-Stage Renal disease (ESRD) who consented to the testing procedure relative to the number of eligible and screened participants
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Limited funds available to complete full recruitment. Enrolment achieved: 90%.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Kevin Burns, MD, CM, Study director, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196610
- Sponsor's protocol ID
- 20140457
- Status last verified
- Mar 2016
- First submitted
- 18 Jul 2014
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656Moody WE, Edwards NC, Chue CD, Ferro CJ, Townend JN. Arterial disease in chronic kidney disease. Heart. 2013 Mar;99(6):365-72. doi: 10.1136/heartjnl-2012-302818. Epub 2012 Oct 31.
PubMed 23118349Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
PubMed 20338492Guerin AP, Blacher J, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness attenuation on survival of patients in end-stage renal failure. Circulation. 2001 Feb 20;103(7):987-92. doi: 10.1161/01.cir.103.7.987.
PubMed 11181474Karras A, Haymann JP, Bozec E, Metzger M, Jacquot C, Maruani G, Houillier P, Froissart M, Stengel B, Guardiola P, Laurent S, Boutouyrie P, Briet M; Nephro Test Study Group. Large artery stiffening and remodeling are independently associated with all-cause mortality and cardiovascular events in chronic kidney disease. Hypertension. 2012 Dec;60(6):1451-7. doi: 10.1161/HYPERTENSIONAHA.112.197210. Epub 2012 Oct 22.
PubMed 23090769Pannier B, Guerin AP, Marchais SJ, Safar ME, London GM. Stiffness of capacitive and conduit arteries: prognostic significance for end-stage renal disease patients. Hypertension. 2005 Apr;45(4):592-6. doi: 10.1161/01.HYP.0000159190.71253.c3. Epub 2005 Mar 7.
PubMed 15753232Boutouyrie P, Fliser D, Goldsmith D, Covic A, Wiecek A, Ortiz A, Martinez-Castelao A, Lindholm B, Massy ZA, Suleymanlar G, Sicari R, Gargani L, Parati G, Mallamaci F, Zoccali C, London GM. Assessment of arterial stiffness for clinical and epidemiological studies: methodological considerations for validation and entry into the European Renal and Cardiovascular Medicine registry. Nephrol Dial Transplant. 2014 Feb;29(2):232-9. doi: 10.1093/ndt/gft309. Epub 2013 Sep 30.
PubMed 24084326Frimodt-Moller M, Nielsen AH, Kamper AL, Strandgaard S. Reproducibility of pulse-wave analysis and pulse-wave velocity determination in chronic kidney disease. Nephrol Dial Transplant. 2008 Feb;23(2):594-600. doi: 10.1093/ndt/gfm470. Epub 2007 Nov 7.
PubMed 17989106Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.
PubMed 20530030Pan CR, Schmaderer C, Roos M, von Eynatten M, Sollinger D, Lutz J, Heemann U, Baumann M. Comparing aortic stiffness in kidney transplant recipients, hemodialysis patients, and patients with chronic renal failure. Clin Transplant. 2011 Jul-Aug;25(4):E463-8. doi: 10.1111/j.1399-0012.2011.01462.x. Epub 2011 Apr 26.
PubMed 21517999Giraudeau B, Mary JY. Planning a reproducibility study: how many subjects and how many replicates per subject for an expected width of the 95 per cent confidence interval of the intraclass correlation coefficient. Stat Med. 2001 Nov 15;20(21):3205-14. doi: 10.1002/sim.935.
PubMed 11746313Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.
PubMed 21453829Rodriguez RA, Cronin V, Ramsay T, Zimmerman D, Ruzicka M, Burns KD. Reproducibility of carotid-femoral pulse wave velocity in end-stage renal disease patients: methodological considerations. Can J Kidney Health Dis. 2016 Apr 1;3:20. doi: 10.1186/s40697-016-0109-6. eCollection 2016.
PubMed 27042326
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness in Healthy Subjects and Patients With End-Stage- Renal Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02196610
- Acronym / sponsor ID
- 20140457
- Conditions
- End-Stage Renal Disease
- Keywords
- End-Stage Renal Disease,, arterial or vascular stiffness,, hemodialysis,, Pulse wave velocity, Renal insufficiency,, tonometry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Limited funds available to complete full recruitment. Enrolment achieved: 90%.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jul 2014 (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.
People with kidney failure have a higher chance of getting disease in the blood vessels and this result in a decreased elasticity of the arteries of their body which make them very stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a method called "applanation tonometry", which measures the "pulse wave velocity" of major blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to determine if we can measure arterial stiffness reliably and accurately using this method in healthy people and in people with kidney failure receiving hemodialysis treatments at our centre. Also, we would like to know how stiff these arteries in healthy people are. If we demonstrate that the method is reliable and accurate in these 2 groups of participants at our centre, a future larger study is planned to determine if we can use measures of arterial stiffness to evaluate the risk of stroke and heart disease in people with kidney failure receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside Campus.
Detailed description
Background:
Cardiovascular (CV) disease is a major cause of morbidity and mortality in patients with end-stage renal disease (ESRD). Arterial stiffness measured by pulse-wave velocity (PWV) has been identified as an independent predictor of fatal CV events in these patients. Our long-term goal is to study the impact of interventions that decrease progressive arterial stiffness on CV mortality in ESRD patients. Thus, we postulate that measurements of PWV during these interventions will predict CV outcome. Before studying this relationship, establishing the feasibility of PWV measurements at our centre is necessary.
Objectives:
- To demonstrate the reliability and accuracy of arterial PWV measurements in healthy subjects and patients with ESRD at our centre, ii) To assess subject satisfaction and level of discomfort associated with the testing procedure, iii) To characterize normative values for the PWV in our two subject groups, and iv) To determine the feasibility of recruitment of patients with ESRD, as a pre-requisite for a larger trial focused on CV outcomes.
Methods:
PWV will be measured consecutively by 2 research assistants in: a) a group of 20 healthy subjects; and b) a group of 20 patients with ESRD on chronic hemodialysis at The Ottawa Hospital. Two consecutive sets of PWV measurements with a time-interval of 1 week (± 2 days) will be obtained in the healthy and ESRD groups (pre-hemodialysis, between 2 consecutive mid-week hemodialysis sessions). To determine the impact of hemodialysis on PWV measures, in a sub-group of 10 ESRD subjects measurements will be taken before and after hemodialysis. The order of testing by the 2 assistants will be randomized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALTHY SUBJECTS group | – | Other: Applanation tonometryA group of 20 healthy staff volunteers identified from the Division of Nephrology, Dept. of Medicine and the Kidney Research Centre at the Ottawa Hospital Research Institute will be invited to participate. Measurements of arterial stiffness will be performed by Applanation tonometry. Healthy status will be defined by a self-reporting questionnaire obtained over the phone prior to enrolment and 2 subsequent non-invasive measurements of arterial blood pressure (BP) prior to testing. Subjects will be included if diastolic BP is ≤ 90 mm Hg and systolic BP ≤ 140 mm Hg on 2 consecutive measurements. |
| END-STAGE RENAL DISEASE (ESRD) group | – | Other: Applanation tonometryA group of 20 patients with stage 5 Chronic Kidney Disease (estimated glomerular filtration rate <15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH) will be invited to participate. Measurements of arterial stiffness will be performed in this group by Applanation tonometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HEALTHY SUBJECTS: 20 healthy staff volunteers. ESRD group: 20 patients with stage 5 CKD (estimated GFR <15 ml/min/m2), who attend chronic hemodialysis treatments at The Ottawa Hospital (TOH).
Key inclusion criteria (6 listed)
- Age: >18 years
- Able to provide informed consent
- Adult patient (age: >18 years) with ESRD (estimated glomerular filtration rate: <15 ml/min/m2)
- Receiving hemodialysis treatments, with no expected renal recovery
- Having received regular in-Centre Hemodialysis at TOH for at least the past 3 weeks
Key exclusion criteria (20 listed)
- History of cardiovascular disease and/or hypertension (blood pressure >140/90 mm Hg)
- History of diabetes mellitus
- History of liver or kidney disease, cancer and/or any lymphoproliferative disease
- Currently receiving medication for any medical condition or illness
- Body Mass Index (BMI) ≥ 30 Kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applanation tonometryAlso: carotid-femoral Pulse wave velocity (c-f-PWV)Two consecutive sets of carotid-femoral Pulse Wave Velocity (PWV) measurements by Applanation tonometry with a time-interval of 1 week will be obtained (1 week ± 2 days). Two research assistants will each perform a carotid-femoral-PWV measurement at each time point with the testing order randomized. | Other | END-STAGE RENAL DISEASE (ESRD) group, HEALTHY SUBJECTS group |
Primary outcome
Reliability of carotid-femoral Pulse Wave Velocity measurements
Time frame: 1 week
We will estimate the Pulse Wave Velocity differences and the intra-class correlation coefficient (ICC) between the 2 examinations (test-retest) recorded in the same subject 1 week apart. We will also estimate the examiner's reliability by the inter-rater agreement through the ICC and limits of agreement.
3 secondary outcomes
Accuracy of the carotid-femoral Pulse Wave Velocity measurements
Time frame: 1 week
Subject satisfaction and procedure discomfort
Time frame: 1 week
Recruitment Efficacy
Time frame: 11 months
Results and safety
The study was stopped early (reason given: Limited funds available to complete full recruitment. Enrolment achieved: 90%.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 23118349Moody WE, Edwards NC, Chue CD, Ferro CJ, Townend JN. Arterial disease in chronic kidney disease. Heart. 2013 Mar;99(6):365-72. doi: 10.1136/heartjnl-2012-302818. Epub 2012 Oct 31.
- Background: PubMed 20338492Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
- Background: PubMed 11181474Guerin AP, Blacher J, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness attenuation on survival of patients in end-stage renal failure. Circulation. 2001 Feb 20;103(7):987-92. doi: 10.1161/01.cir.103.7.987.
- Background: PubMed 23090769Karras A, Haymann JP, Bozec E, Metzger M, Jacquot C, Maruani G, Houillier P, Froissart M, Stengel B, Guardiola P, Laurent S, Boutouyrie P, Briet M; Nephro Test Study Group. Large artery stiffening and remodeling are independently associated with all-cause mortality and cardiovascular events in chronic kidney disease. Hypertension. 2012 Dec;60(6):1451-7. doi: 10.1161/HYPERTENSIONAHA.112.197210. Epub 2012 Oct 22.
- Background: PubMed 15753232Pannier B, Guerin AP, Marchais SJ, Safar ME, London GM. Stiffness of capacitive and conduit arteries: prognostic significance for end-stage renal disease patients. Hypertension. 2005 Apr;45(4):592-6. doi: 10.1161/01.HYP.0000159190.71253.c3. Epub 2005 Mar 7.
- Background: PubMed 24084326Boutouyrie P, Fliser D, Goldsmith D, Covic A, Wiecek A, Ortiz A, Martinez-Castelao A, Lindholm B, Massy ZA, Suleymanlar G, Sicari R, Gargani L, Parati G, Mallamaci F, Zoccali C, London GM. Assessment of arterial stiffness for clinical and epidemiological studies: methodological considerations for validation and entry into the European Renal and Cardiovascular Medicine registry. Nephrol Dial Transplant. 2014 Feb;29(2):232-9. doi: 10.1093/ndt/gft309. Epub 2013 Sep 30.
- Background: PubMed 17989106Frimodt-Moller M, Nielsen AH, Kamper AL, Strandgaard S. Reproducibility of pulse-wave analysis and pulse-wave velocity determination in chronic kidney disease. Nephrol Dial Transplant. 2008 Feb;23(2):594-600. doi: 10.1093/ndt/gfm470. Epub 2007 Nov 7.
- Background: PubMed 20530030Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.
- Background: PubMed 21517999Pan CR, Schmaderer C, Roos M, von Eynatten M, Sollinger D, Lutz J, Heemann U, Baumann M. Comparing aortic stiffness in kidney transplant recipients, hemodialysis patients, and patients with chronic renal failure. Clin Transplant. 2011 Jul-Aug;25(4):E463-8. doi: 10.1111/j.1399-0012.2011.01462.x. Epub 2011 Apr 26.
- Background: PubMed 11746313Giraudeau B, Mary JY. Planning a reproducibility study: how many subjects and how many replicates per subject for an expected width of the 95 per cent confidence interval of the intraclass correlation coefficient. Stat Med. 2001 Nov 15;20(21):3205-14. doi: 10.1002/sim.935.
- Background: PubMed 21453829Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.
- Individual participant dataSharing planned: No
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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.
Kevin Burns, MD, CM study director
Ottawa Hospital Research Institute
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 End-Stage Renal Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 2 May 2016. 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 Canada. 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 was stopped early (reason given: Limited funds available to complete full recruitment. Enrolment achieved: 90%.). Results are not available in the source record.
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?
Reliability of carotid-femoral Pulse Wave Velocity measurements (time frame: 1 week). 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 NCT02196610, which also lists 13 linked publications.
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 2 May 2016.