<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/NCT04472637</url>
  </required_header>
  <id_info>
    <org_study_id>arterial stiffness in HD</org_study_id>
    <nct_id>NCT04472637</nct_id>
  </id_info>
  <brief_title>Atorvastatin Effects On Arterial Stiffness In Hemodialysis</brief_title>
  <official_title>Atorvastatin Effects On Arterial Stiffness In Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research aims to assess effects of atorvastatin on arterial stiffness in hemodialysis&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease (CVD) is the most common cause of morbidity and mortality among&#xD;
      patients with end-stage renal disease (ESRD) on hemodialysis (HD).&#xD;
&#xD;
      CVD are present since the early stages of chronic kidney disease (CKD) and reach around 30 to&#xD;
      44% of those beginning hemodialysis. Macrovascular disease develops rapidly in uremic&#xD;
      patients and is responsible for the high incidence of ischemic heart disease, left&#xD;
      ventricular (LV) hypertrophy, congestive heart failure, sudden death, and stroke.&#xD;
&#xD;
      Compared with the general population, the incidence of cardiovascular (CV) events among&#xD;
      patients with ESRD is significantly higher, but it does not seem to be fully explained by the&#xD;
      increased incidence of conventional risk factors alone. It has been hypothesized that HD&#xD;
      patients are exposed to unique renal and HD-related risk factors that predispose them to an&#xD;
      increased rate of CV events. Research efforts have expanded understanding of the contribution&#xD;
      made by vascular pathologies to this burden.&#xD;
&#xD;
      Clinicians now recognize that defects in the vascular wall are the bases of many CV events,&#xD;
      and early detection and intervention in subclinical vascular disease are fundamental for&#xD;
      preventing and controlling cardiovascular events. Changes in the vasculature include&#xD;
      endothelial dysfunction (ED), smooth muscle cell hyperplasia/hypertrophy, vascular&#xD;
      calcification, and arterial stiffness.&#xD;
&#xD;
      Arterial stiffness is one of the vascular pathologies in HD patients. Recent studies&#xD;
      examining cardiovascular complications in dialysis patients focused on atherosclerosis,&#xD;
      including arterial stiffness and wall thickness changes as a major contributing factors for&#xD;
      CV events. It was shown that stiffening of arteries is associated with increased&#xD;
      cardiovascular mortality and morbidity.&#xD;
&#xD;
      Arteriosclerosis refers to the reduced arterial compliance due to increased fibrosis, loss of&#xD;
      elasticity, and vessel wall calcification affecting the media of large and middle-sized&#xD;
      arteries. These arterial wall changes are influenced not only by nonspecific factors, such as&#xD;
      age, genetics, hypertension, diabetes, lipid abnormalities, inflammation, and/or common&#xD;
      atherosclerosis, but also by parameter(s) associated with the presence of uremia per se.&#xD;
&#xD;
      Arterial stiffening in patients with CKD and ESRD occurs at an accelerated rate compared with&#xD;
      the normal ageing process and arteriosclerosis. As bone mineral metabolism worsens with&#xD;
      advancement to ESRD, hyperphosphatemia, secondary hyperparathyroidism and inhibited vitamin D&#xD;
      synthesis result in vascular calcification that causes hardening of the arteries. Other&#xD;
      factors linked to the uremic environment, such as anaemia, endothelial dysfunction,&#xD;
      neuro-hormonal activation and inflammation, play important roles.&#xD;
&#xD;
      Arterial stiffness can be assessed noninvasively with the use of pulse wave velocity (PWV)&#xD;
      measurement. The aortic pulse wave velocity (APWV) reflects central arterial stiffness. APWV&#xD;
      is a predictor of cardiovascular outcome in patients with hypertension, diabetes, end-stage&#xD;
      renal disease, and elderly hospitalized subjects.&#xD;
&#xD;
      Statins or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors are&#xD;
      considered first-line treatment for elevated low-density lipoprotein cholesterol (LDL-C)&#xD;
      levels, as large-scale, randomized clinical trials have demonstrated their clinical benefits&#xD;
      in primary and secondary prevention of cardiovascular events. Background and clinical studies&#xD;
      have also shown beneficial actions of statins for the vasculature that may extend above their&#xD;
      lipid lowering properties, such as improvement of endothelial function, inhibition of&#xD;
      vascular smooth muscle cell proliferation, and reduction of vascular inflammation. It has&#xD;
      been also proposed that such pleiotropic effects of statins may translate into a beneficial&#xD;
      impact on arterial stiffness. Atorvastatin reduced arterial stiffness in patients with&#xD;
      hypertension and hypercholesterolemia, diabetes mellitus. Fassett at al. found that&#xD;
      atorvastatin reduced arterial stiffness in CKD patients (stage 2-4) but they did not include&#xD;
      patients on maintenance haemodialysis in their study. We want to illustrate if these&#xD;
      beneficial effects on arterial stiffness will be present or not among haemodialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This research is a double-blinded , placebo-controlled, randomized clinical trial. Fifty patients with end-stage renal disease (ESRD) receiving hemodialysis treatment will be enrolled in the study.&#xD;
Patients will be randomly assigned using block randomization method into two study groups:&#xD;
Experimental group (25 patients): They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.&#xD;
Control group (25 patients): They will receive a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks).&#xD;
Allocation concealment: will be ensured using sealed closed envelop randomization technique, every patient will be given an identification code.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>a double blinded study as participants, health care providers as well as the outcome assessor will be unaware about the type of treatment each patient receive.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change in Aortic pulse wave velocity (PWV)</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>the procedure was done at least 30 minutes after the dialysis session. Measurements were made after 10 minutes of rest in a supine position with a suitable cuff placed in the upper arm (the non-arteriovenous fistula arm in the hemodialysis group) and a connecting tube linking the cuff to a recorder device.Three consecutive measurements were taken automatically with 30 seconds of duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Augmentation index (AIx)</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>It is a surrogate index of arterial stiffness which measures pulse wave reflections that significantly influence the central pressure profile. It is directly related to peripheral arterial stiffness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Central systolic blood pressure (CSP)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Central aortic systolic blood pressure is a parameter that strongly reflects vascular changes of central elastic arteries compared to peripheral brachial blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Peripheral blood pressure (PBP)</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>change in peripheral systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in central pulse pressure (PP)</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>will be clalculated from the central waveform</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Arterial Stiffness</condition>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>atorvastatin 10 mg, as one tablet /day for 24 weeks.</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <other_name>Lipitor, Ator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks)</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on regular hemodialysis treatment for more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diabetes mellitus.&#xD;
&#xD;
          -  Patients with known severe valvular heart disease.&#xD;
&#xD;
          -  Irregular heart rhythm.&#xD;
&#xD;
          -  History of aortic surgery/prosthetic aorta.&#xD;
&#xD;
          -  Acute liver disease.&#xD;
&#xD;
          -  Patients receiving lipid lowering drugs.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  History of myocardial infraction in the previous 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Mamdouh Elsayed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>El Hassan M Ayman, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Aexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21526</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Stack AG, Bloembergen WE. Prevalence and clinical correlates of coronary artery disease among new dialysis patients in the United States: a cross-sectional study. J Am Soc Nephrol. 2001 Jul;12(7):1516-1523. doi: 10.1681/ASN.V1271516.</citation>
    <PMID>11423581</PMID>
  </reference>
  <reference>
    <citation>Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434.</citation>
    <PMID>10318666</PMID>
  </reference>
  <reference>
    <citation>Chertow GM, Raggi P, Chasan-Taber S, Bommer J, Holzer H, Burke SK. Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2004 Jun;19(6):1489-96. doi: 10.1093/ndt/gfh125. Epub 2004 Apr 21.</citation>
    <PMID>15102961</PMID>
  </reference>
  <reference>
    <citation>Simionescu M. Implications of early structural-functional changes in the endothelium for vascular disease. Arterioscler Thromb Vasc Biol. 2007 Feb;27(2):266-74. doi: 10.1161/01.ATV.0000253884.13901.e4. Epub 2006 Nov 30.</citation>
    <PMID>17138941</PMID>
  </reference>
  <reference>
    <citation>Bellasi A, Ferramosca E, Ratti C. Arterial stiffness in chronic kidney disease: the usefulness of a marker of vascular damage. Int J Nephrol. 2011;2011:734832. doi: 10.4061/2011/734832. Epub 2011 May 23.</citation>
    <PMID>21660313</PMID>
  </reference>
  <reference>
    <citation>Briet M, Boutouyrie P, Laurent S, London GM. Arterial stiffness and pulse pressure in CKD and ESRD. Kidney Int. 2012 Aug;82(4):388-400. doi: 10.1038/ki.2012.131.</citation>
    <PMID>22534962</PMID>
  </reference>
  <reference>
    <citation>Adenwalla SF, Graham-Brown MPM, Leone FMT, Burton JO, McCann GP. The importance of accurate measurement of aortic stiffness in patients with chronic kidney disease and end-stage renal disease. Clin Kidney J. 2017 Aug;10(4):503-515. doi: 10.1093/ckj/sfx028. Epub 2017 May 10.</citation>
    <PMID>28852490</PMID>
  </reference>
  <reference>
    <citation>Palaniswamy C, Selvaraj DR, Selvaraj T, Sukhija R. Mechanisms underlying pleiotropic effects of statins. Am J Ther. 2010 Jan-Feb;17(1):75-8. doi: 10.1097/MJT.0b013e31819cdc86.</citation>
    <PMID>19451808</PMID>
  </reference>
  <reference>
    <citation>Sarafidis PA, Kanaki AI, Lasaridis AN. Effects of statins on blood pressure: a review of the experimental and clinical evidence. Curr Vasc Pharmacol. 2007 Apr;5(2):155-61. doi: 10.2174/157016107780368307.</citation>
    <PMID>17430220</PMID>
  </reference>
  <reference>
    <citation>Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.</citation>
    <PMID>23449607</PMID>
  </reference>
  <reference>
    <citation>Davenport C, Ashley DT, O'Sullivan EP, McHenry CM, Agha A, Thompson CJ, O'Gorman DJ, Smith D. The Effects of Atorvastatin on Arterial Stiffness in Male Patients with Type 2 Diabetes. J Diabetes Res. 2015;2015:846807. doi: 10.1155/2015/846807. Epub 2015 Apr 30.</citation>
    <PMID>26064990</PMID>
  </reference>
  <reference>
    <citation>Fassett RG, Robertson IK, Ball MJ, Geraghty DP, Sharman JE, Coombes JS. Effects of atorvastatin on arterial stiffness in chronic kidney disease: a randomised controlled trial. J Atheroscler Thromb. 2010 Mar 31;17(3):235-41. doi: 10.5551/jat.2683. Epub 2009 Dec 24.</citation>
    <PMID>20032570</PMID>
  </reference>
  <reference>
    <citation>Wassertheurer S, Kropf J, Weber T, van der Giet M, Baulmann J, Ammer M, Hametner B, Mayer CC, Eber B, Magometschnigg D. A new oscillometric method for pulse wave analysis: comparison with a common tonometric method. J Hum Hypertens. 2010 Aug;24(8):498-504. doi: 10.1038/jhh.2010.27. Epub 2010 Mar 18.</citation>
    <PMID>20237499</PMID>
  </reference>
  <reference>
    <citation>Hametner B, Wassertheurer S, Kropf J, Mayer C, Eber B, Weber T. Oscillometric estimation of aortic pulse wave velocity: comparison with intra-aortic catheter measurements. Blood Press Monit. 2013 Jun;18(3):173-6. doi: 10.1097/MBP.0b013e3283614168.</citation>
    <PMID>23571229</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>statin, hemodialysis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04472637
org study id: arterial stiffness in HD
nct id: NCT04472637
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This research aims to assess effects of atorvastatin on arterial stiffness in hemodialysis
      patients
Cardiovascular disease (CVD) is the most common cause of morbidity and mortality among
      patients with end-stage renal disease (ESRD) on hemodialysis (HD).

      CVD are present since the early stages of chronic kidney disease (CKD) and reach around 30 to
      44% of those beginning hemodialysis. Macrovascular disease develops rapidly in uremic
      patients and is responsible for the high incidence of ischemic heart disease, left
      ventricular (LV) hypertrophy, congestive heart failure, sudden death, and stroke.

      Compared with the general population, the incidence of cardiovascular (CV) events among
      patients with ESRD is significantly higher, but it does not seem to be fully explained by the
      increased incidence of conventional risk factors alone. It has been hypothesized that HD
      patients are exposed to unique renal and HD-related risk factors that predispose them to an
      increased rate of CV events. Research efforts have expanded understanding of the contribution
      made by vascular pathologies to this burden.

      Clinicians now recognize that defects in the vascular wall are the bases of many CV events,
      and early detection and intervention in subclinical vascular disease are fundamental for
      preventing and controlling cardiovascular events. Changes in the vasculature include
      endothelial dysfunction (ED), smooth muscle cell hyperplasia/hypertrophy, vascular
      calcification, and arterial stiffness.

      Arterial stiffness is one of the vascular pathologies in HD patients. Recent studies
      examining cardiovascular complications in dialysis patients focused on atherosclerosis,
      including arterial stiffness and wall thickness changes as a major contributing factors for
      CV events. It was shown that stiffening of arteries is associated with increased
      cardiovascular mortality and morbidity.

      Arteriosclerosis refers to the reduced arterial compliance due to increased fibrosis, loss of
      elasticity, and vessel wall calcification affecting the media of large and middle-sized
      arteries. These arterial wall changes are influenced not only by nonspecific factors, such as
      age, genetics, hypertension, diabetes, lipid abnormalities, inflammation, and/or common
      atherosclerosis, but also by parameter(s) associated with the presence of uremia per se.

      Arterial stiffening in patients with CKD and ESRD occurs at an accelerated rate compared with
      the normal ageing process and arteriosclerosis. As bone mineral metabolism worsens with
      advancement to ESRD, hyperphosphatemia, secondary hyperparathyroidism and inhibited vitamin D
      synthesis result in vascular calcification that causes hardening of the arteries. Other
      factors linked to the uremic environment, such as anaemia, endothelial dysfunction,
      neuro-hormonal activation and inflammation, play important roles.

      Arterial stiffness can be assessed noninvasively with the use of pulse wave velocity (PWV)
      measurement. The aortic pulse wave velocity (APWV) reflects central arterial stiffness. APWV
      is a predictor of cardiovascular outcome in patients with hypertension, diabetes, end-stage
      renal disease, and elderly hospitalized subjects.

      Statins or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors are
      considered first-line treatment for elevated low-density lipoprotein cholesterol (LDL-C)
      levels, as large-scale, randomized clinical trials have demonstrated their clinical benefits
      in primary and secondary prevention of cardiovascular events. Background and clinical studies
      have also shown beneficial actions of statins for the vasculature that may extend above their
      lipid lowering properties, such as improvement of endothelial function, inhibition of
      vascular smooth muscle cell proliferation, and reduction of vascular inflammation. It has
      been also proposed that such pleiotropic effects of statins may translate into a beneficial
      impact on arterial stiffness. Atorvastatin reduced arterial stiffness in patients with
      hypertension and hypercholesterolemia, diabetes mellitus. Fassett at al. found that
      atorvastatin reduced arterial stiffness in CKD patients (stage 2-4) but they did not include
      patients on maintenance haemodialysis in their study. We want to illustrate if these
      beneficial effects on arterial stiffness will be present or not among haemodialysis patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This research is a double-blinded , placebo-controlled, randomized clinical trial. Fifty patients with end-stage renal disease (ESRD) receiving hemodialysis treatment will be enrolled in the study.
Patients will be randomly assigned using block randomization method into two study groups:
Experimental group (25 patients): They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.
Control group (25 patients): They will receive a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks).
Allocation concealment: will be ensured using sealed closed envelop randomization technique, every patient will be given an identification code.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: a double blinded study as participants, health care providers as well as the outcome assessor will be unaware about the type of treatment each patient receive.
measure: change in Aortic pulse wave velocity (PWV)
time frame: baseline, 24 weeks
description: the procedure was done at least 30 minutes after the dialysis session. Measurements were made after 10 minutes of rest in a supine position with a suitable cuff placed in the upper arm (the non-arteriovenous fistula arm in the hemodialysis group) and a connecting tube linking the cuff to a recorder device.Three consecutive measurements were taken automatically with 30 seconds of duration.
measure: change in Augmentation index (AIx)
time frame: baseline, 24 weeks
description: It is a surrogate index of arterial stiffness which measures pulse wave reflections that significantly influence the central pressure profile. It is directly related to peripheral arterial stiffness.
measure: change in Central systolic blood pressure (CSP)
time frame: 24 weeks
description: Central aortic systolic blood pressure is a parameter that strongly reflects vascular changes of central elastic arteries compared to peripheral brachial blood pressure
measure: change in Peripheral blood pressure (PBP)
time frame: baseline, 24 weeks
description: change in peripheral systolic and diastolic blood pressure
measure: change in central pulse pressure (PP)
time frame: baseline, 24 weeks
description: will be clalculated from the central waveform
arm group label: Atorvastatin
arm group type: Experimental
description: They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.
arm group label: placebo
arm group type: Placebo Comparator
description: They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 24 weeks.
intervention type: Drug
intervention name: Atorvastatin
description: atorvastatin 10 mg, as one tablet /day for 24 weeks.
arm group label: Atorvastatin
other name: Lipitor, Ator
intervention type: Drug
intervention name: Placebo
description: a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks)
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed Mamdouh Elsayed, MD
role: Principal Investigator
affiliation: lecturer
last name: El Hassan M Ayman, MSc
role: Study Chair
affiliation: Assistant lecturer
facility: 
country: Egypt
citation: Stack AG, Bloembergen WE. Prevalence and clinical correlates of coronary artery disease among new dialysis patients in the United States: a cross-sectional study. J Am Soc Nephrol. 2001 Jul;12(7):1516-1523. doi: 10.1681/ASN.V1271516.
PMID: 11423581
citation: Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434.
PMID: 10318666
citation: Chertow GM, Raggi P, Chasan-Taber S, Bommer J, Holzer H, Burke SK. Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2004 Jun;19(6):1489-96. doi: 10.1093/ndt/gfh125. Epub 2004 Apr 21.
PMID: 15102961
citation: Simionescu M. Implications of early structural-functional changes in the endothelium for vascular disease. Arterioscler Thromb Vasc Biol. 2007 Feb;27(2):266-74. doi: 10.1161/01.ATV.0000253884.13901.e4. Epub 2006 Nov 30.
PMID: 17138941
citation: Bellasi A, Ferramosca E, Ratti C. Arterial stiffness in chronic kidney disease: the usefulness of a marker of vascular damage. Int J Nephrol. 2011;2011:734832. doi: 10.4061/2011/734832. Epub 2011 May 23.
PMID: 21660313
citation: Briet M, Boutouyrie P, Laurent S, London GM. Arterial stiffness and pulse pressure in CKD and ESRD. Kidney Int. 2012 Aug;82(4):388-400. doi: 10.1038/ki.2012.131.
PMID: 22534962
citation: Adenwalla SF, Graham-Brown MPM, Leone FMT, Burton JO, McCann GP. The importance of accurate measurement of aortic stiffness in patients with chronic kidney disease and end-stage renal disease. Clin Kidney J. 2017 Aug;10(4):503-515. doi: 10.1093/ckj/sfx028. Epub 2017 May 10.
PMID: 28852490
citation: Palaniswamy C, Selvaraj DR, Selvaraj T, Sukhija R. Mechanisms underlying pleiotropic effects of statins. Am J Ther. 2010 Jan-Feb;17(1):75-8. doi: 10.1097/MJT.0b013e31819cdc86.
PMID: 19451808
citation: Sarafidis PA, Kanaki AI, Lasaridis AN. Effects of statins on blood pressure: a review of the experimental and clinical evidence. Curr Vasc Pharmacol. 2007 Apr;5(2):155-61. doi: 10.2174/157016107780368307.
PMID: 17430220
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responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
investigator title: Lecturer
mesh term: Atorvastatin
sharing ipd: Undecided