<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/NCT03773991</url>
  </required_header>
  <id_info>
    <org_study_id>110256</org_study_id>
    <nct_id>NCT03773991</nct_id>
  </id_info>
  <brief_title>Dyspnea Assessment in Hemodialysis Patients</brief_title>
  <official_title>Multimodal Assessment of Dyspnea, Cardiopulmonary Structure and Function in Chronic Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shortness of breath is very common among patients on dialysis for kidney failure; however,&#xD;
      its causes are often not understood. This study will explore the lungs and the heart of these&#xD;
      patients to determine the causes of shortness of breath. The amount of salt in the body&#xD;
      tissues, which tends to accumulate in dialysis patients and can also cause shortness of&#xD;
      breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and&#xD;
      x-rays to take images of the body interior will be employed; in addition, breathing tests,&#xD;
      questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited&#xD;
      and have two visits: one at the beginning of the study and one year later to observe any&#xD;
      changes in the lungs, heart and salt accumulation over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      The available evidence suggest that End-Stage Renal Disease (ESRD) and hemodialysis (HD) have&#xD;
      harmful effects on the lungs; the investigators hypothesize that these recurring pulmonary&#xD;
      insults, in an analogous way as recurring myocardial ischemic injury for the heart, cause&#xD;
      long term impairment in the pulmonary parenchyma, airways and circulation. In addition,&#xD;
      observational studies have reported that dyspnea is a common symptom among ESRD patients on&#xD;
      chronic HD treatment; however, no study up to now has directly addressed the issue, so that&#xD;
      the relationship between dyspnea and pulmonary involvement in the HD population remains&#xD;
      poorly understood.&#xD;
&#xD;
      The aim of this study is to explore the pathophysiological basis of dyspnea in patients with&#xD;
      end stage renal disease on chronic HD, by using state-of-the-art imaging and functional study&#xD;
      techniques.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      This is an exploratory study involving a single center recruiting patients from the prevalent&#xD;
      dialysis population of London, Ontario. 20 patients on maintenance hemodialysis will be&#xD;
      recruited. The patients will undergo imaging, functional studies and blood sampling at the&#xD;
      Robarts Research Institute on a non-dialysis day, during the short interval in the dialysis&#xD;
      schedule, at baseline and after one year.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      Blood Collection: blood will be collected from a venous access for standard-of-care tests,&#xD;
      uremia and inflammation biomarkers.&#xD;
&#xD;
      Dyspnea Assessment: dyspnea will be assessed with the following self-administered&#xD;
      questionnaires: Modified Medical Research Council Breathlessness Scale, the University of&#xD;
      California, San Diego Shortness of Breath Questionnaire Pulmonary Function Tests: spirometry&#xD;
      and plethysmography pre and post salbutamol administration, carbon monoxide diffusion (DLCO)&#xD;
      and the fractional exhaled nitric oxide (FeNO) will be evaluated.&#xD;
&#xD;
      Six Minute Walk Test: the subjects able to do so will perform a six minute walk test, their&#xD;
      dyspnea and overall fatigue at baseline and at the end of the exercise will be evaluated&#xD;
      using the Borg Scale.&#xD;
&#xD;
      Lung MRI: a proton MRI with ultrashort echo time (UTE) acquisition sequences for the study of&#xD;
      lung parenchyma and lung water will be employed. Images will be acquired twice, both pre and&#xD;
      post a bronchodilator (salbutamol) challenge.&#xD;
&#xD;
      Sodium MRI: a proton T1 weighted fast-low-angle-shot (FLASH)- sequence will be acquired to&#xD;
      delineate the anatomy of the lower leg. Then, a sodium MRI study of the subjects' legs (~5 cm&#xD;
      below the knee) will be obtained with the custom-made sodium coil at 3.0 Tesla.&#xD;
&#xD;
      Water content will also be quantified using proton-MRI with fat-suppressed inversion recovery&#xD;
      sequence with proton density contrast.&#xD;
&#xD;
      Chest CT: a high-resolution chest CT scan will be performed using a 64-slice CT scanner. A&#xD;
      low radiation dose protocol will be employed. A qualitative and quantitative evaluation of&#xD;
      pulmonary airways, blood vessels and parenchyma will be performed.&#xD;
&#xD;
      2D Transthoracic Echocardiography: images will be taken in the left lateral decubitus. Images&#xD;
      and loops from standard parasternal long axis and short axis, subcostal, apical 4, 2 and 3-&#xD;
      chamber views will be recorded and analyzed for: global longitudinal strain, left ventricular&#xD;
      ejection fraction, left ventricular mass, left atrial volume, right ventricular diameter,&#xD;
      right atrial volume, right ventricular wall thickness, tricuspid annular plane systolic&#xD;
      excursion, pulmonary artery systolic pressure, E/A ratio, E/E' ratio at the basal&#xD;
      interventricular septum, aortic, mitral, tricuspid and pulmonary valve qualitative and&#xD;
      quantitative function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment issues: Restrictions associated with the COVID-19 pandemic have made much of the&#xD;
    research procedures unfeasible due to organizational and safety issues (for both staff and&#xD;
    patient protection).&#xD;
  </why_stopped>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">February 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Modified Medical Research Council scale score.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline dyspnea measured by Modified Medical Research Council scale. 0-4 from lowest (no dyspnea) to highest (most severe dyspnea).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline University of California, San Diego Shortness of Breath Questionnaire score.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire.&#xD;
0-120 from lowest (no dyspnea) to highest (most severe dyspnea).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline pulmonary artery diameter.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline lung total blood vessel volume.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline lung total blood vessel volume in ml by chest Computed Tomography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline lung total airway count.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline lung total airway count by chest Computed Tomography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline lung low attenuation area.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline lung low attenuation area by chest Computed Tomography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline lung water content.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline soft tissue sodium content.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One year changes in Modified Medical Research Council scale score.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of dyspnea measured by Modified Medical Research Council scale at one year versus baseline.&#xD;
0-4 from lowest (no dyspnea) to highest (most severe dyspnea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline modified Medical Research Council scale score and one year morbidity.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>One year morbidity risk by modified Medical Research Council scale baseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline modified Medical Research Council scale score and one year mortality.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>One year mortality risk by modified Medical Research Council scale baseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and soft tissue sodium content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between soft tissue sodium content (mmol/L) and modified Medical Research Council scale score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and pulmonary artery diameter.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between modified Medical Research Council scale score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and lung total blood vessel volume.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between modified Medical Research Council scale score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and lung total airway count.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between modified Medical Research Council scale score and lung total airway count, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and lung low attenuation areas.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between modified Medical Research Council scale score and lung low attenuation areas, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified Medical Research Council scale score and lung total water content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between modified Medical Research Council scale score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in University of California, San Diego Shortness of Breath Questionnaire score.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire at one year versus baseline.&#xD;
0-120 from lowest (no dyspnea) to highest (most severe dyspnea).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year morbidity.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>One year morbidity risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year mortality.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>One year mortality risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and soft tissue sodium content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between soft tissue sodium content (mmol/L) and University of California, San Diego Shortness of Breath Questionnaire score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in lung total blood vessel volume.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of lung total blood vessel volume (in milliliters) at one year versus baseline, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in lung total airway count.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of lung total airway count at one year versus baseline, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in lung water content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of lung water content (in arbitrary units) at one year versus baseline, measured by proton Magnetic Resonance Imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in lung low attenuation areas.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of lung low attenuation areas at one year versus baseline, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in pulmonary artery diameter.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of pulmonary artery diameter (in millimeters) at one year versus baseline, measured by chest Computed Tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline pulmonary artery systolic pressure.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline pulmonary artery systolic pressure (in mmHg), measured by transthoracic doppler echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in pulmonary artery systolic pressure.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of pulmonary artery systolic pressure in mmHg at one year versus baseline, measured by transthoracic doppler echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline fractional exhaled nitric oxide.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline fractional exhaled nitric oxide measured (in parts per billion).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in fractional exhaled nitric oxide.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of fractional exhaled nitric oxide measured (in parts per billion) at one year versus baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline forced expiratory volume at one second/forced vital capacity ratio.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline forced expiratory volume at one second/forced vital capacity ratio by pulmonary function tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in forced expiratory volume at one second/forced vital capacity ratio.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of forced expiratory volume at one second/forced vital capacity ratio at one year versus baseline, by pulmonary function tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline diffusing capacity of the lung for carbon monoxide.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline diffusing capacity of the lung for carbon monoxide (in ml/min/kPa), by pulmonary function tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in diffusing capacity of the lung for carbon monoxide.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of diffusing capacity of the lung for carbon monoxide (in ml/min/kPa) at one year versus baseline, by pulmonary function tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline six minute walk distance.</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline six minute walk distance (in meters) measured by six minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in six minute walk distance.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of six minute walk distance (in meters) at one year versus baseline, measured by six minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year changes in soft tissue sodium content.</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Comparison of soft tissue sodium content (in mmol/L) at one year versus baseline, measured by sodium Magnetic Resonance Imaging.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Dyspnea; Uremic</condition>
  <condition>End Stage Renal Disease</condition>
  <condition>Chronic Lung Disease</condition>
  <condition>Chronic Heart Disease</condition>
  <condition>Hemodialysis-Induced Symptom</condition>
  <condition>Sodium Excess</condition>
  <arm_group>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
    <description>Patients on chronic hemodialysis therapy due to end-stage renal disease.&#xD;
Proton Lung MRI&#xD;
Sodium MRI of the leg&#xD;
Chest CT&#xD;
Transthoracic Echocardiography&#xD;
Fractional Exhaled Nitric Oxide&#xD;
Six-Minute Walk Test&#xD;
Pulmonary Function Tests&#xD;
Blood sampling&#xD;
Self-administered dyspnea questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung MRI</intervention_name>
    <description>Proton Lung Magnetic Resonance Imaging</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sodium MRI</intervention_name>
    <description>Sodium Soft Tissue Magnetic Resonance Imaging</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Chest CT</intervention_name>
    <description>High-resolution Quantitative Chest CT</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Transthoracic 2D Speckle-Tracking Echocardiography</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fractional Exhaled Nitric Oxide</intervention_name>
    <description>Fractional Exhaled Nitric Oxide testing</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pulmonary Function Tests</intervention_name>
    <description>Spirometry and Plethysmography</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood Sampling</intervention_name>
    <description>Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Six-Minute Walk Test</intervention_name>
    <description>Six-Minute Walk Test</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dyspnea Questionnaires</intervention_name>
    <description>Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale</description>
    <arm_group_label>Maintenance Hemodialysis Patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patients for this trial will be recruited from incident and prevalent hemodialysis&#xD;
        patients receiving care for their kidney disease from the Dialysis Service at London Health&#xD;
        Sciences Centre, London Ontario. Up to 20 eligible patients will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal to or greater than 18 years.&#xD;
&#xD;
          -  Dialysis vintage equal to or greater than 3 months.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Smoking history of more than 10 packs/year.&#xD;
&#xD;
          -  Active tobacco and/or cannabis smoking.&#xD;
&#xD;
          -  Diagnosed chronic pulmonary disease.&#xD;
&#xD;
          -  Severe heart failure (NYHA class IV)&#xD;
&#xD;
          -  Active infection (including tuberculosis) or malignancy.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Inability to give consent or understand written information.&#xD;
&#xD;
          -  Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a&#xD;
             12-seconds breathhold.&#xD;
&#xD;
          -  Inability to perform spirometry or plethysmography maneuvers.&#xD;
&#xD;
          -  Inability to tolerate MRI due to patient size and/or known history of claustrophobia.&#xD;
&#xD;
          -  Subject has an implanted mechanically, electrically or magnetically activated device&#xD;
             or any metal in their body which cannot be removed, including but not limited to&#xD;
             pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips,&#xD;
             bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical&#xD;
             staples (including clips or metallic sutures and/or ear implants.).&#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>Christopher W McIntyre, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Murtagh FE, Addington-Hall JM, Edmonds PM, Donohoe P, Carey I, Jenkins K, Higginson IJ. Symptoms in advanced renal disease: a cross-sectional survey of symptom prevalence in stage 5 chronic kidney disease managed without dialysis. J Palliat Med. 2007 Dec;10(6):1266-76. doi: 10.1089/jpm.2007.0017.</citation>
    <PMID>18095805</PMID>
  </reference>
  <reference>
    <citation>Fairshter RD, Vaziri ND, Mirahmadi MK. Lung pathology in chronic hemodialysis patients. Int J Artif Organs. 1982 Mar;5(2):97-100.</citation>
    <PMID>7095887</PMID>
  </reference>
  <reference>
    <citation>Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.</citation>
    <PMID>23449536</PMID>
  </reference>
  <reference>
    <citation>Nascimento MM, Qureshi AR, Stenvinkel P, Pecoits-Filho R, Heimburger O, Cederholm T, Lindholm B, Barany P. Malnutrition and inflammation are associated with impaired pulmonary function in patients with chronic kidney disease. Nephrol Dial Transplant. 2004 Jul;19(7):1823-8. doi: 10.1093/ndt/gfh190. Epub 2004 May 18.</citation>
    <PMID>15150347</PMID>
  </reference>
  <reference>
    <citation>Wallin CJ, Jacobson SH, Leksell LG. Subclinical pulmonary oedema and intermittent haemodialysis. Nephrol Dial Transplant. 1996 Nov;11(11):2269-75. doi: 10.1093/oxfordjournals.ndt.a027147.</citation>
    <PMID>8941589</PMID>
  </reference>
  <reference>
    <citation>Bolignano D, Rastelli S, Agarwal R, Fliser D, Massy Z, Ortiz A, Wiecek A, Martinez-Castelao A, Covic A, Goldsmith D, Suleymanlar G, Lindholm B, Parati G, Sicari R, Gargani L, Mallamaci F, London G, Zoccali C. Pulmonary hypertension in CKD. Am J Kidney Dis. 2013 Apr;61(4):612-22. doi: 10.1053/j.ajkd.2012.07.029. Epub 2012 Nov 17. Erratum In: Am J Kidney Dis. 2015 Mar;65(3):524.</citation>
    <PMID>23164943</PMID>
  </reference>
  <reference>
    <citation>Barak M, Nakhoul F, Katz Y. Pathophysiology and clinical implications of microbubbles during hemodialysis. Semin Dial. 2008 May-Jun;21(3):232-8. doi: 10.1111/j.1525-139X.2008.00424.x. Epub 2008 Mar 18.</citation>
    <PMID>18363602</PMID>
  </reference>
  <reference>
    <citation>Plesner LL, Warming PE, Nielsen TL, Dalsgaard M, Schou M, Host U, Rydahl C, Brandi L, Kober L, Vestbo J, Iversen K. Chronic obstructive pulmonary disease in patients with end-stage kidney disease on hemodialysis. Hemodial Int. 2016 Jan;20(1):68-77. doi: 10.1111/hdi.12342. Epub 2015 Aug 5.</citation>
    <PMID>26245152</PMID>
  </reference>
  <reference>
    <citation>Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.</citation>
    <PMID>22530005</PMID>
  </reference>
  <reference>
    <citation>Herrero JA, Alvarez-Sala JL, Coronel F, Moratilla C, Gamez C, Sanchez-Alarcos JM, Barrientos A. Pulmonary diffusing capacity in chronic dialysis patients. Respir Med. 2002 Jul;96(7):487-92. doi: 10.1053/rmed.2002.1346.</citation>
    <PMID>12194631</PMID>
  </reference>
  <reference>
    <citation>Kovacevic P, Stanetic M, Rajkovaca Z, Meyer FJ, Vukoja M. Changes in spirometry over time in uremic patients receiving long-term hemodialysis therapy. Pneumologia. 2011 Jan-Mar;60(1):36-9.</citation>
    <PMID>21545062</PMID>
  </reference>
  <reference>
    <citation>McIntyre CW, Odudu A. Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial. 2014 Mar;27(2):87-97. doi: 10.1111/sdi.12197.</citation>
    <PMID>24738144</PMID>
  </reference>
  <reference>
    <citation>Belem LC, Zanetti G, Souza AS Jr, Hochhegger B, Guimaraes MD, Nobre LF, Rodrigues RS, Marchiori E. Metastatic pulmonary calcification: state-of-the-art review focused on imaging findings. Respir Med. 2014 May;108(5):668-76. doi: 10.1016/j.rmed.2014.01.012. Epub 2014 Feb 6.</citation>
    <PMID>24529738</PMID>
  </reference>
  <reference>
    <citation>Incalzi RA, Corsonello A, Pedone C, Battaglia S, Paglino G, Bellia V; Extrapulmonary Consequences of COPD in the Elderly Study Investigators. Chronic renal failure: a neglected comorbidity of COPD. Chest. 2010 Apr;137(4):831-7. doi: 10.1378/chest.09-1710. Epub 2009 Nov 10.</citation>
    <PMID>19903974</PMID>
  </reference>
  <reference>
    <citation>Romoff MS, Keusch G, Campese VM, Wang MS, Friedler RM, Weidmann P, Massry SG. Effect of sodium intake on plasma catecholamines in normal subjects. J Clin Endocrinol Metab. 1979 Jan;48(1):26-31. doi: 10.1210/jcem-48-1-26. No abstract available.</citation>
    <PMID>422701</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Chris McIntyre</investigator_full_name>
    <investigator_title>Professor of Medicine, Medical Biophysics and Paediatrics, University of Western Ontario. Director of The Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre.</investigator_title>
  </responsible_party>
  <keyword>Dyspnea</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>End Stage Renal Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
  </intervention_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/NCT03773991
org study id: 110256
nct id: NCT03773991
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shortness of breath is very common among patients on dialysis for kidney failure; however,
      its causes are often not understood. This study will explore the lungs and the heart of these
      patients to determine the causes of shortness of breath. The amount of salt in the body
      tissues, which tends to accumulate in dialysis patients and can also cause shortness of
      breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and
      x-rays to take images of the body interior will be employed; in addition, breathing tests,
      questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited
      and have two visits: one at the beginning of the study and one year later to observe any
      changes in the lungs, heart and salt accumulation over time.
Rationale:

      The available evidence suggest that End-Stage Renal Disease (ESRD) and hemodialysis (HD) have
      harmful effects on the lungs; the investigators hypothesize that these recurring pulmonary
      insults, in an analogous way as recurring myocardial ischemic injury for the heart, cause
      long term impairment in the pulmonary parenchyma, airways and circulation. In addition,
      observational studies have reported that dyspnea is a common symptom among ESRD patients on
      chronic HD treatment; however, no study up to now has directly addressed the issue, so that
      the relationship between dyspnea and pulmonary involvement in the HD population remains
      poorly understood.

      The aim of this study is to explore the pathophysiological basis of dyspnea in patients with
      end stage renal disease on chronic HD, by using state-of-the-art imaging and functional study
      techniques.

      Study Design:

      This is an exploratory study involving a single center recruiting patients from the prevalent
      dialysis population of London, Ontario. 20 patients on maintenance hemodialysis will be
      recruited. The patients will undergo imaging, functional studies and blood sampling at the
      Robarts Research Institute on a non-dialysis day, during the short interval in the dialysis
      schedule, at baseline and after one year.

      Study Procedures:

      Blood Collection: blood will be collected from a venous access for standard-of-care tests,
      uremia and inflammation biomarkers.

      Dyspnea Assessment: dyspnea will be assessed with the following self-administered
      questionnaires: Modified Medical Research Council Breathlessness Scale, the University of
      California, San Diego Shortness of Breath Questionnaire Pulmonary Function Tests: spirometry
      and plethysmography pre and post salbutamol administration, carbon monoxide diffusion (DLCO)
      and the fractional exhaled nitric oxide (FeNO) will be evaluated.

      Six Minute Walk Test: the subjects able to do so will perform a six minute walk test, their
      dyspnea and overall fatigue at baseline and at the end of the exercise will be evaluated
      using the Borg Scale.

      Lung MRI: a proton MRI with ultrashort echo time (UTE) acquisition sequences for the study of
      lung parenchyma and lung water will be employed. Images will be acquired twice, both pre and
      post a bronchodilator (salbutamol) challenge.

      Sodium MRI: a proton T1 weighted fast-low-angle-shot (FLASH)- sequence will be acquired to
      delineate the anatomy of the lower leg. Then, a sodium MRI study of the subjects' legs (~5 cm
      below the knee) will be obtained with the custom-made sodium coil at 3.0 Tesla.

      Water content will also be quantified using proton-MRI with fat-suppressed inversion recovery
      sequence with proton density contrast.

      Chest CT: a high-resolution chest CT scan will be performed using a 64-slice CT scanner. A
      low radiation dose protocol will be employed. A qualitative and quantitative evaluation of
      pulmonary airways, blood vessels and parenchyma will be performed.

      2D Transthoracic Echocardiography: images will be taken in the left lateral decubitus. Images
      and loops from standard parasternal long axis and short axis, subcostal, apical 4, 2 and 3-
      chamber views will be recorded and analyzed for: global longitudinal strain, left ventricular
      ejection fraction, left ventricular mass, left atrial volume, right ventricular diameter,
      right atrial volume, right ventricular wall thickness, tricuspid annular plane systolic
      excursion, pulmonary artery systolic pressure, E/A ratio, E/E' ratio at the basal
      interventricular septum, aortic, mitral, tricuspid and pulmonary valve qualitative and
      quantitative function.
observational model: Cohort
time perspective: Prospective
measure: Baseline Modified Medical Research Council scale score.
time frame: Baseline
description: Baseline dyspnea measured by Modified Medical Research Council scale. 0-4 from lowest (no dyspnea) to highest (most severe dyspnea).
measure: Baseline University of California, San Diego Shortness of Breath Questionnaire score.
time frame: Baseline
description: Baseline dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire.
0-120 from lowest (no dyspnea) to highest (most severe dyspnea).
measure: Baseline pulmonary artery diameter.
time frame: Baseline
description: Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.
measure: Baseline lung total blood vessel volume.
time frame: Baseline
description: Baseline lung total blood vessel volume in ml by chest Computed Tomography.
measure: Baseline lung total airway count.
time frame: Baseline
description: Baseline lung total airway count by chest Computed Tomography.
measure: Baseline lung low attenuation area.
time frame: Baseline
description: Baseline lung low attenuation area by chest Computed Tomography.
measure: Baseline lung water content.
time frame: Baseline
description: Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.
measure: Baseline soft tissue sodium content.
time frame: Baseline
description: Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.
measure: One year changes in Modified Medical Research Council scale score.
time frame: Baseline and one year
description: Comparison of dyspnea measured by Modified Medical Research Council scale at one year versus baseline.
0-4 from lowest (no dyspnea) to highest (most severe dyspnea).
measure: Correlation between baseline modified Medical Research Council scale score and one year morbidity.
time frame: Baseline and one year
description: One year morbidity risk by modified Medical Research Council scale baseline score.
measure: Correlation between baseline modified Medical Research Council scale score and one year mortality.
time frame: Baseline and one year
description: One year mortality risk by modified Medical Research Council scale baseline score.
measure: Correlation between modified Medical Research Council scale score and soft tissue sodium content.
time frame: Baseline and one year
description: Correlation coefficient between soft tissue sodium content (mmol/L) and modified Medical Research Council scale score.
measure: Correlation between modified Medical Research Council scale score and pulmonary artery diameter.
time frame: Baseline and one year
description: Correlation coefficient between modified Medical Research Council scale score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.
measure: Correlation between modified Medical Research Council scale score and lung total blood vessel volume.
time frame: Baseline and one year
description: Correlation coefficient between modified Medical Research Council scale score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.
measure: Correlation between modified Medical Research Council scale score and lung total airway count.
time frame: Baseline and one year
description: Correlation coefficient between modified Medical Research Council scale score and lung total airway count, measured by chest Computed Tomography.
measure: Correlation between modified Medical Research Council scale score and lung low attenuation areas.
time frame: Baseline and one year
description: Correlation coefficient between modified Medical Research Council scale score and lung low attenuation areas, measured by chest Computed Tomography.
measure: Correlation between modified Medical Research Council scale score and lung total water content.
time frame: Baseline and one year
description: Correlation coefficient between modified Medical Research Council scale score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.
measure: One year changes in University of California, San Diego Shortness of Breath Questionnaire score.
time frame: Baseline and one year
description: Comparison of dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire at one year versus baseline.
0-120 from lowest (no dyspnea) to highest (most severe dyspnea).
measure: Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year morbidity.
time frame: Baseline and one year
description: One year morbidity risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.
measure: Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year mortality.
time frame: Baseline and one year
description: One year mortality risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter.
time frame: Baseline and one year
description: Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and soft tissue sodium content.
time frame: Baseline and one year
description: Correlation coefficient between soft tissue sodium content (mmol/L) and University of California, San Diego Shortness of Breath Questionnaire score.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume.
time frame: Baseline and one year
description: Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count.
time frame: Baseline and one year
description: Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count, measured by chest Computed Tomography.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas.
time frame: Baseline and one year
description: Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas, measured by chest Computed Tomography.
measure: Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content.
time frame: Baseline and one year
description: Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.
measure: One year changes in lung total blood vessel volume.
time frame: Baseline and one year
description: Comparison of lung total blood vessel volume (in milliliters) at one year versus baseline, measured by chest Computed Tomography.
measure: One year changes in lung total airway count.
time frame: Baseline and one year
description: Comparison of lung total airway count at one year versus baseline, measured by chest Computed Tomography.
measure: One year changes in lung water content.
time frame: Baseline and one year
description: Comparison of lung water content (in arbitrary units) at one year versus baseline, measured by proton Magnetic Resonance Imaging.
measure: One year changes in lung low attenuation areas.
time frame: Baseline and one year
description: Comparison of lung low attenuation areas at one year versus baseline, measured by chest Computed Tomography.
measure: One year changes in pulmonary artery diameter.
time frame: Baseline and one year
description: Comparison of pulmonary artery diameter (in millimeters) at one year versus baseline, measured by chest Computed Tomography.
measure: Baseline pulmonary artery systolic pressure.
time frame: Baseline
description: Baseline pulmonary artery systolic pressure (in mmHg), measured by transthoracic doppler echocardiography.
measure: One year changes in pulmonary artery systolic pressure.
time frame: Baseline and one year
description: Comparison of pulmonary artery systolic pressure in mmHg at one year versus baseline, measured by transthoracic doppler echocardiography.
measure: Baseline fractional exhaled nitric oxide.
time frame: Baseline
description: Baseline fractional exhaled nitric oxide measured (in parts per billion).
measure: One year changes in fractional exhaled nitric oxide.
time frame: Baseline and one year
description: Comparison of fractional exhaled nitric oxide measured (in parts per billion) at one year versus baseline.
measure: Baseline forced expiratory volume at one second/forced vital capacity ratio.
time frame: Baseline
description: Baseline forced expiratory volume at one second/forced vital capacity ratio by pulmonary function tests.
measure: One year changes in forced expiratory volume at one second/forced vital capacity ratio.
time frame: Baseline and one year
description: Comparison of forced expiratory volume at one second/forced vital capacity ratio at one year versus baseline, by pulmonary function tests.
measure: Baseline diffusing capacity of the lung for carbon monoxide.
time frame: Baseline
description: Baseline diffusing capacity of the lung for carbon monoxide (in ml/min/kPa), by pulmonary function tests.
measure: One year changes in diffusing capacity of the lung for carbon monoxide.
time frame: Baseline and one year
description: Comparison of diffusing capacity of the lung for carbon monoxide (in ml/min/kPa) at one year versus baseline, by pulmonary function tests
measure: Baseline six minute walk distance.
time frame: Baseline
description: Baseline six minute walk distance (in meters) measured by six minute walk test.
measure: One year changes in six minute walk distance.
time frame: Baseline and one year
description: Comparison of six minute walk distance (in meters) at one year versus baseline, measured by six minute walk test.
measure: One year changes in soft tissue sodium content.
time frame: Baseline and one year
description: Comparison of soft tissue sodium content (in mmol/L) at one year versus baseline, measured by sodium Magnetic Resonance Imaging.
arm group label: Maintenance Hemodialysis Patients
description: Patients on chronic hemodialysis therapy due to end-stage renal disease.
Proton Lung MRI
Sodium MRI of the leg
Chest CT
Transthoracic Echocardiography
Fractional Exhaled Nitric Oxide
Six-Minute Walk Test
Pulmonary Function Tests
Blood sampling
Self-administered dyspnea questionnaires
intervention type: Diagnostic Test
intervention name: Lung MRI
description: Proton Lung Magnetic Resonance Imaging
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Sodium MRI
description: Sodium Soft Tissue Magnetic Resonance Imaging
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Chest CT
description: High-resolution Quantitative Chest CT
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Transthoracic 2D Speckle-Tracking Echocardiography
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Fractional Exhaled Nitric Oxide
description: Fractional Exhaled Nitric Oxide testing
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Pulmonary Function Tests
description: Spirometry and Plethysmography
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Blood Sampling
description: Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Six-Minute Walk Test
description: Six-Minute Walk Test
arm group label: Maintenance Hemodialysis Patients
intervention type: Diagnostic Test
intervention name: Dyspnea Questionnaires
description: Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale
arm group label: Maintenance Hemodialysis Patients
Plasma and serum.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher W McIntyre, MD PhD
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
citation: Murtagh FE, Addington-Hall JM, Edmonds PM, Donohoe P, Carey I, Jenkins K, Higginson IJ. Symptoms in advanced renal disease: a cross-sectional survey of symptom prevalence in stage 5 chronic kidney disease managed without dialysis. J Palliat Med. 2007 Dec;10(6):1266-76. doi: 10.1089/jpm.2007.0017.
PMID: 18095805
citation: Fairshter RD, Vaziri ND, Mirahmadi MK. Lung pathology in chronic hemodialysis patients. Int J Artif Organs. 1982 Mar;5(2):97-100.
PMID: 7095887
citation: Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
PMID: 23449536
citation: Nascimento MM, Qureshi AR, Stenvinkel P, Pecoits-Filho R, Heimburger O, Cederholm T, Lindholm B, Barany P. Malnutrition and inflammation are associated with impaired pulmonary function in patients with chronic kidney disease. Nephrol Dial Transplant. 2004 Jul;19(7):1823-8. doi: 10.1093/ndt/gfh190. Epub 2004 May 18.
PMID: 15150347
citation: Wallin CJ, Jacobson SH, Leksell LG. Subclinical pulmonary oedema and intermittent haemodialysis. Nephrol Dial Transplant. 1996 Nov;11(11):2269-75. doi: 10.1093/oxfordjournals.ndt.a027147.
PMID: 8941589
citation: Bolignano D, Rastelli S, Agarwal R, Fliser D, Massy Z, Ortiz A, Wiecek A, Martinez-Castelao A, Covic A, Goldsmith D, Suleymanlar G, Lindholm B, Parati G, Sicari R, Gargani L, Mallamaci F, London G, Zoccali C. Pulmonary hypertension in CKD. Am J Kidney Dis. 2013 Apr;61(4):612-22. doi: 10.1053/j.ajkd.2012.07.029. Epub 2012 Nov 17. Erratum In: Am J Kidney Dis. 2015 Mar;65(3):524.
PMID: 23164943
citation: Barak M, Nakhoul F, Katz Y. Pathophysiology and clinical implications of microbubbles during hemodialysis. Semin Dial. 2008 May-Jun;21(3):232-8. doi: 10.1111/j.1525-139X.2008.00424.x. Epub 2008 Mar 18.
PMID: 18363602
citation: Plesner LL, Warming PE, Nielsen TL, Dalsgaard M, Schou M, Host U, Rydahl C, Brandi L, Kober L, Vestbo J, Iversen K. Chronic obstructive pulmonary disease in patients with end-stage kidney disease on hemodialysis. Hemodial Int. 2016 Jan;20(1):68-77. doi: 10.1111/hdi.12342. Epub 2015 Aug 5.
PMID: 26245152
citation: Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.
PMID: 22530005
citation: Herrero JA, Alvarez-Sala JL, Coronel F, Moratilla C, Gamez C, Sanchez-Alarcos JM, Barrientos A. Pulmonary diffusing capacity in chronic dialysis patients. Respir Med. 2002 Jul;96(7):487-92. doi: 10.1053/rmed.2002.1346.
PMID: 12194631
citation: Kovacevic P, Stanetic M, Rajkovaca Z, Meyer FJ, Vukoja M. Changes in spirometry over time in uremic patients receiving long-term hemodialysis therapy. Pneumologia. 2011 Jan-Mar;60(1):36-9.
PMID: 21545062
citation: McIntyre CW, Odudu A. Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial. 2014 Mar;27(2):87-97. doi: 10.1111/sdi.12197.
PMID: 24738144
citation: Belem LC, Zanetti G, Souza AS Jr, Hochhegger B, Guimaraes MD, Nobre LF, Rodrigues RS, Marchiori E. Metastatic pulmonary calcification: state-of-the-art review focused on imaging findings. Respir Med. 2014 May;108(5):668-76. doi: 10.1016/j.rmed.2014.01.012. Epub 2014 Feb 6.
PMID: 24529738
citation: Incalzi RA, Corsonello A, Pedone C, Battaglia S, Paglino G, Bellia V; Extrapulmonary Consequences of COPD in the Elderly Study Investigators. Chronic renal failure: a neglected comorbidity of COPD. Chest. 2010 Apr;137(4):831-7. doi: 10.1378/chest.09-1710. Epub 2009 Nov 10.
PMID: 19903974
citation: Romoff MS, Keusch G, Campese VM, Wang MS, Friedler RM, Weidmann P, Massry SG. Effect of sodium intake on plasma catecholamines in normal subjects. J Clin Endocrinol Metab. 1979 Jan;48(1):26-31. doi: 10.1210/jcem-48-1-26. No abstract available.
PMID: 422701
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Chris McIntyre
investigator title: Professor of Medicine, Medical Biophysics and Paediatrics, University of Western Ontario. Director of The Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre.
mesh term: Lung Diseases
mesh term: Dyspnea
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Heart Diseases
mesh term: Nitric Oxide
sharing ipd: No