<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02196610</url>
  </required_header>
  <id_info>
    <org_study_id>20140457</org_study_id>
    <nct_id>NCT02196610</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Arterial Stiffness in Hemodialysis Patients</brief_title>
  <official_title>Arterial Stiffness in Healthy Subjects and Patients With End-Stage- Renal Disease: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ottawa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with kidney failure have a higher chance of getting disease in the blood vessels and&#xD;
      this result in a decreased elasticity of the arteries of their body which make them very&#xD;
      stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk&#xD;
      of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a&#xD;
      method called &quot;applanation tonometry&quot;, which measures the &quot;pulse wave velocity&quot; of major&#xD;
      blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to&#xD;
      determine if we can measure arterial stiffness reliably and accurately using this method in&#xD;
      healthy people and in people with kidney failure receiving hemodialysis treatments at our&#xD;
      centre. Also, we would like to know how stiff these arteries in healthy people are. If we&#xD;
      demonstrate that the method is reliable and accurate in these 2 groups of participants at our&#xD;
      centre, a future larger study is planned to determine if we can use measures of arterial&#xD;
      stiffness to evaluate the risk of stroke and heart disease in people with kidney failure&#xD;
      receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside&#xD;
      Campus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Cardiovascular (CV) disease is a major cause of morbidity and mortality in patients with&#xD;
      end-stage renal disease (ESRD). Arterial stiffness measured by pulse-wave velocity (PWV) has&#xD;
      been identified as an independent predictor of fatal CV events in these patients. Our&#xD;
      long-term goal is to study the impact of interventions that decrease progressive arterial&#xD;
      stiffness on CV mortality in ESRD patients. Thus, we postulate that measurements of PWV&#xD;
      during these interventions will predict CV outcome. Before studying this relationship,&#xD;
      establishing the feasibility of PWV measurements at our centre is necessary.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      i) To demonstrate the reliability and accuracy of arterial PWV measurements in healthy&#xD;
      subjects and patients with ESRD at our centre, ii) To assess subject satisfaction and level&#xD;
      of discomfort associated with the testing procedure, iii) To characterize normative values&#xD;
      for the PWV in our two subject groups, and iv) To determine the feasibility of recruitment of&#xD;
      patients with ESRD, as a pre-requisite for a larger trial focused on CV outcomes.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      PWV will be measured consecutively by 2 research assistants in: a) a group of 20 healthy&#xD;
      subjects; and b) a group of 20 patients with ESRD on chronic hemodialysis at The Ottawa&#xD;
      Hospital. Two consecutive sets of PWV measurements with a time-interval of 1 week (± 2 days)&#xD;
      will be obtained in the healthy and ESRD groups (pre-hemodialysis, between 2 consecutive&#xD;
      mid-week hemodialysis sessions). To determine the impact of hemodialysis on PWV measures, in&#xD;
      a sub-group of 10 ESRD subjects measurements will be taken before and after hemodialysis. The&#xD;
      order of testing by the 2 assistants will be randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Limited funds available to complete full recruitment. Enrolment achieved: 90%.&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reliability of carotid-femoral Pulse Wave Velocity measurements</measure>
    <time_frame>1 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the carotid-femoral Pulse Wave Velocity measurements</measure>
    <time_frame>1 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction and procedure discomfort</measure>
    <time_frame>1 week</time_frame>
    <description>This will be accomplished by surveying subjects at the end of the testing procedure using a Likert-type questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment Efficacy</measure>
    <time_frame>11 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Normative Pulse Wave Velocity Values</measure>
    <time_frame>11 months</time_frame>
    <description>We will calculate the mean, standard deviation and 95% confidence interval of the pulse wave velocity values and Augmentation index in our defined populations.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>End-Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>HEALTHY SUBJECTS group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>END-STAGE RENAL DISEASE (ESRD) group</arm_group_label>
    <description>A group of 20 patients with stage 5 Chronic Kidney Disease (estimated glomerular filtration rate &lt;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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Applanation tonometry</intervention_name>
    <description>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.</description>
    <arm_group_label>END-STAGE RENAL DISEASE (ESRD) group</arm_group_label>
    <arm_group_label>HEALTHY SUBJECTS group</arm_group_label>
    <other_name>carotid-femoral Pulse wave velocity (c-f-PWV)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HEALTHY SUBJECTS: 20 healthy staff volunteers.&#xD;
&#xD;
        ESRD group: 20 patients with stage 5 CKD (estimated GFR &lt;15 ml/min/m2), who attend chronic&#xD;
        hemodialysis treatments at The Ottawa Hospital (TOH).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        HEALTHY SUBJECT GROUP&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age: &gt;18 years&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  History of cardiovascular disease and/or hypertension (blood pressure &gt;140/90 mm Hg)&#xD;
&#xD;
          -  History of diabetes mellitus&#xD;
&#xD;
          -  History of liver or kidney disease, cancer and/or any lymphoproliferative disease&#xD;
&#xD;
          -  Currently receiving medication for any medical condition or illness&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 30 Kg/m2&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any condition that limits functional ability and precludes participation&#xD;
&#xD;
          -  Current smoker (&gt;15 cigarettes per day) in the last 6 months.&#xD;
&#xD;
          -  Former smoker (&gt; 20 cigarettes per day) who stopped smoking &lt; 2 years ago.&#xD;
&#xD;
          -  Excessive alcohol intake (men &gt;14 drinks per week; women: &gt; 9 drinks per week).&#xD;
&#xD;
          -  Psychoactive or performance-enhancing drug abuse.&#xD;
&#xD;
        END-STAGE RENAL DISEASE (ESRD) GROUP&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (age: &gt;18 years) with ESRD (estimated glomerular filtration rate: &lt;15&#xD;
             ml/min/m2)&#xD;
&#xD;
          -  Receiving hemodialysis treatments, with no expected renal recovery&#xD;
&#xD;
          -  Having received regular in-Centre Hemodialysis at TOH for at least the past 3 weeks&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation (as it frequently results in transient or persistent rapid heart&#xD;
             rates and these changes overestimate aortic stiffness).&#xD;
&#xD;
          -  Active cancer or history of cancer in the past 5 years.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any condition that limit the patient's ambulatory ability and preclude participation&#xD;
             on this basis&#xD;
&#xD;
          -  Mechanical, bioprosthetic heart valves or mechanical assisting devices (these&#xD;
             conditions may change myocardial stiffness and the volumetric properties of the left&#xD;
             ventricle leading to diastolic dysfunction and these physiologic changes may modify&#xD;
             the waveforms of the cf- APWV).&#xD;
&#xD;
          -  Pre-dialysis systolic blood pressure ≥ 200 mm Hg recorded in the last 6 dialysis&#xD;
             treatments (2 weeks).&#xD;
&#xD;
          -  Inability to measure blood pressure in at least one arm.&#xD;
&#xD;
          -  Current smoker (&gt;15 cigarettes per day) in the last 6 months [Daily cigarette&#xD;
             consumption (&gt;15 cigarettes per day) adjusted by age, education level and other&#xD;
             confounders has been found to be independently associated with the risk of&#xD;
             hypertension].&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Burns, MD, CM</last_name>
    <role>Study Director</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital - Riverside campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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. Erratum In: N Engl J Med. 2008;18(4):4.</citation>
    <PMID>15385656</PMID>
  </reference>
  <reference>
    <citation>Moody 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.</citation>
    <PMID>23118349</PMID>
  </reference>
  <reference>
    <citation>Vlachopoulos 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.</citation>
    <PMID>20338492</PMID>
  </reference>
  <reference>
    <citation>Guerin 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.</citation>
    <PMID>11181474</PMID>
  </reference>
  <reference>
    <citation>Karras 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.</citation>
    <PMID>23090769</PMID>
  </reference>
  <reference>
    <citation>Pannier 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.</citation>
    <PMID>15753232</PMID>
  </reference>
  <reference>
    <citation>Boutouyrie 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.</citation>
    <PMID>24084326</PMID>
  </reference>
  <reference>
    <citation>Frimodt-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.</citation>
    <PMID>17989106</PMID>
  </reference>
  <reference>
    <citation>Reference 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.</citation>
    <PMID>20530030</PMID>
  </reference>
  <reference>
    <citation>Pan 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.</citation>
    <PMID>21517999</PMID>
  </reference>
  <reference>
    <citation>Giraudeau 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.</citation>
    <PMID>11746313</PMID>
  </reference>
  <reference>
    <citation>Cavalcante 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.</citation>
    <PMID>21453829</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>April 28, 2016</last_update_submitted>
  <last_update_submitted_qc>April 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>End-Stage Renal Disease,</keyword>
  <keyword>arterial or vascular stiffness,</keyword>
  <keyword>hemodialysis,</keyword>
  <keyword>Pulse wave velocity</keyword>
  <keyword>Renal insufficiency,</keyword>
  <keyword>tonometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02196610
org study id: 20140457
nct id: NCT02196610
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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:

      i) 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.
observational model: Case-Control
time perspective: Prospective
measure: Reliability of carotid-femoral Pulse Wave Velocity measurements
time frame: 1 week
description: 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.
measure: Accuracy of the carotid-femoral Pulse Wave Velocity measurements
time frame: 1 week
description: 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
measure: Subject satisfaction and procedure discomfort
time frame: 1 week
description: This will be accomplished by surveying subjects at the end of the testing procedure using a Likert-type questionnaire
measure: Recruitment Efficacy
time frame: 11 months
description: 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
measure: Normative Pulse Wave Velocity Values
time frame: 11 months
description: We will calculate the mean, standard deviation and 95% confidence interval of the pulse wave velocity values and Augmentation index in our defined populations.
arm group label: HEALTHY SUBJECTS group
description: 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.
arm group label: END-STAGE RENAL DISEASE (ESRD) group
description: 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.
intervention type: Other
intervention name: Applanation tonometry
description: 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.
arm group label: END-STAGE RENAL DISEASE (ESRD) group
arm group label: HEALTHY SUBJECTS group
other name: carotid-femoral Pulse wave velocity (c-f-PWV)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Burns, MD, CM
role: Study Director
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
citation: 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. Erratum In: N Engl J Med. 2008;18(4):4.
PMID: 15385656
citation: Moody 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.
PMID: 23118349
citation: Vlachopoulos 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.
PMID: 20338492
citation: Guerin 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.
PMID: 11181474
citation: Karras 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.
PMID: 23090769
citation: Pannier 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.
PMID: 15753232
citation: Boutouyrie 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.
PMID: 24084326
citation: Frimodt-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.
PMID: 17989106
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responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: No