<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/NCT03306160</url>
  </required_header>
  <id_info>
    <org_study_id>C-HEMO001</org_study_id>
    <nct_id>NCT03306160</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis</brief_title>
  <acronym>C-HEMO</acronym>
  <official_title>Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis: the C-HEMO Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study which aims to explore the significance of brachial and&#xD;
      central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients&#xD;
      with end stage renal disease who are treated with hemodialysis. Enrolled patients will&#xD;
      receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time&#xD;
      dialysis after enrollment. And their cardiovascular events and deaths at first and third year&#xD;
      will be followed-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol of this study was approved by the local ethical review board. The including&#xD;
      criteria: 1) ESRD treated with hemodialysis for more than 3 months prior to study enrollment;&#xD;
      2) agree to participate the study and sign informed written consent; 3) available for&#xD;
      long-term follow-up. The excluding criteria: 1)chronic atrial fibrillation or other cardiac&#xD;
      arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the&#xD;
      one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during&#xD;
      the previous month; 4) congestive heart failure class IV based on the New York Heart&#xD;
      Association classification; 5) malignancy or any other condition with poor prognosis; 6)&#xD;
      antihypertensive treatment during one month prior to enrollment. After enrollment, every&#xD;
      patient will receive a question-based interview to obtain medical history and the following&#xD;
      examinations and tests: anthropometric parameters measurement including body height, weight;&#xD;
      biochemical tests including vein blood and urine. At the first-time dialysis after&#xD;
      enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure&#xD;
      monitoring using a well validated and commercial device Mobil-O-Graph (IEM, Germany).&#xD;
      Brachial blood pressure are measured for each patient before every dialysis for at three&#xD;
      month. Then one-year and three-year cardiovascular events and deaths will be followed-up. The&#xD;
      primary outcome measures are as follows: deaths and cardiovascular events including nonfatal&#xD;
      myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or&#xD;
      resuscitated cardiac arrest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">October 9, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 9, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>3 year</time_frame>
    <description>nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiovascular deaths</measure>
    <time_frame>3 year</time_frame>
    <description>cardiovascular deaths</description>
  </primary_outcome>
  <primary_outcome>
    <measure>all-cause deaths</measure>
    <time_frame>3 year</time_frame>
    <description>all-cause deaths</description>
  </primary_outcome>
  <enrollment type="Anticipated">900</enrollment>
  <condition>End Stage Renal Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>48-hour blood pressure ambulatory monitoring</intervention_name>
    <description>at first-time dialysis after enrollment, each patient will receive brachial and central blood pressure monitoring for 48 hours using a validate and commercially available device Mobil-O-Graph (IEM, Germany).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with end-stage renal disease treated with hemodialysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with end-stage renal disease treated with hemodialysis for more than 3 months&#xD;
             prior to study enrollment;&#xD;
&#xD;
          -  agree to participate the study and sign informed written consent;&#xD;
&#xD;
          -  available for long-term follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic atrial fibrillation or other cardiac arrhythmia;&#xD;
&#xD;
          -  nonfunctional arteriovenous fistula in the contralateral brachial area of the one used&#xD;
             for dialysis;&#xD;
&#xD;
          -  myocardial infarction, angina pectoris and ischemic stroke during the previous month;&#xD;
&#xD;
          -  congestive heart failure class IV based on the New York Heart Association&#xD;
             classification;&#xD;
&#xD;
          -  malignancy or any other condition with poor prognosis;&#xD;
&#xD;
          -  antihypertensive treatment during 1 month prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yawei Xu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shikai Yu, MD</last_name>
    <phone>+86 18801790211</phone>
    <email>shikaiyu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shikai Yu</last_name>
      <phone>+86 18801790211</phone>
      <email>YuShikai@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sumida K, Molnar MZ, Potukuchi PK, Thomas F, Lu JL, Yamagata K, Kalantar-Zadeh K, Kovesdy CP. Pre-end-stage renal disease visit-to-visit systolic blood pressure variability and post-end-stage renal disease mortality in incident dialysis patients. J Hypertens. 2017 Sep;35(9):1816-1824. doi: 10.1097/HJH.0000000000001376.</citation>
    <PMID>28399042</PMID>
  </reference>
  <reference>
    <citation>Karpetas A, Sarafidis PA, Georgianos PI, Protogerou A, Vakianis P, Koutroumpas G, Raptis V, Stamatiadis DN, Syrganis C, Liakopoulos V, Efstratiadis G, Lasaridis AN. Ambulatory recording of wave reflections and arterial stiffness during intra- and interdialytic periods in patients treated with dialysis. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):630-8. doi: 10.2215/CJN.08180814. Epub 2015 Jan 29.</citation>
    <PMID>25635033</PMID>
  </reference>
  <reference>
    <citation>Covic A, Goldsmith DJ, Panaghiu L, Covic M, Sedor J. Analysis of the effect of hemodialysis on peripheral and central arterial pressure waveforms. Kidney Int. 2000 Jun;57(6):2634-43. doi: 10.1046/j.1523-1755.2000.00124.x.</citation>
    <PMID>10844634</PMID>
  </reference>
  <reference>
    <citation>Ohno Y, Kanno Y, Takenaka T. Central blood pressure and chronic kidney disease. World J Nephrol. 2016 Jan 6;5(1):90-100. doi: 10.5527/wjn.v5.i1.90.</citation>
    <PMID>26788468</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 28, 2018</last_update_submitted>
  <last_update_submitted_qc>October 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Ya-Wei Xu</investigator_full_name>
    <investigator_title>The chief director of department of cardiology</investigator_title>
  </responsible_party>
  <keyword>central blood pressure</keyword>
  <keyword>ambulatory blood pressure monitoring</keyword>
  <keyword>blood pressure variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03306160
org study id: C-HEMO001
nct id: NCT03306160
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective cohort study which aims to explore the significance of brachial and
      central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients
      with end stage renal disease who are treated with hemodialysis. Enrolled patients will
      receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time
      dialysis after enrollment. And their cardiovascular events and deaths at first and third year
      will be followed-up.
The protocol of this study was approved by the local ethical review board. The including
      criteria: 1) ESRD treated with hemodialysis for more than 3 months prior to study enrollment;
      2) agree to participate the study and sign informed written consent; 3) available for
      long-term follow-up. The excluding criteria: 1)chronic atrial fibrillation or other cardiac
      arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the
      one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during
      the previous month; 4) congestive heart failure class IV based on the New York Heart
      Association classification; 5) malignancy or any other condition with poor prognosis; 6)
      antihypertensive treatment during one month prior to enrollment. After enrollment, every
      patient will receive a question-based interview to obtain medical history and the following
      examinations and tests: anthropometric parameters measurement including body height, weight;
      biochemical tests including vein blood and urine. At the first-time dialysis after
      enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure
      monitoring using a well validated and commercial device Mobil-O-Graph (IEM, Germany).
      Brachial blood pressure are measured for each patient before every dialysis for at three
      month. Then one-year and three-year cardiovascular events and deaths will be followed-up. The
      primary outcome measures are as follows: deaths and cardiovascular events including nonfatal
      myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or
      resuscitated cardiac arrest.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular events
time frame: 3 year
description: nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest
measure: cardiovascular deaths
time frame: 3 year
description: cardiovascular deaths
measure: all-cause deaths
time frame: 3 year
description: all-cause deaths
intervention type: Other
intervention name: 48-hour blood pressure ambulatory monitoring
description: at first-time dialysis after enrollment, each patient will receive brachial and central blood pressure monitoring for 48 hours using a validate and commercially available device Mobil-O-Graph (IEM, Germany).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yawei Xu, MD, PhD
role: Principal Investigator
affiliation: Shanghai 10th People's Hospital
last name: Shikai Yu, MD
phone: +86 18801790211
email: shikaiyu@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
citation: Sumida K, Molnar MZ, Potukuchi PK, Thomas F, Lu JL, Yamagata K, Kalantar-Zadeh K, Kovesdy CP. Pre-end-stage renal disease visit-to-visit systolic blood pressure variability and post-end-stage renal disease mortality in incident dialysis patients. J Hypertens. 2017 Sep;35(9):1816-1824. doi: 10.1097/HJH.0000000000001376.
PMID: 28399042
citation: Karpetas A, Sarafidis PA, Georgianos PI, Protogerou A, Vakianis P, Koutroumpas G, Raptis V, Stamatiadis DN, Syrganis C, Liakopoulos V, Efstratiadis G, Lasaridis AN. Ambulatory recording of wave reflections and arterial stiffness during intra- and interdialytic periods in patients treated with dialysis. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):630-8. doi: 10.2215/CJN.08180814. Epub 2015 Jan 29.
PMID: 25635033
citation: Covic A, Goldsmith DJ, Panaghiu L, Covic M, Sedor J. Analysis of the effect of hemodialysis on peripheral and central arterial pressure waveforms. Kidney Int. 2000 Jun;57(6):2634-43. doi: 10.1046/j.1523-1755.2000.00124.x.
PMID: 10844634
citation: Ohno Y, Kanno Y, Takenaka T. Central blood pressure and chronic kidney disease. World J Nephrol. 2016 Jan 6;5(1):90-100. doi: 10.5527/wjn.v5.i1.90.
PMID: 26788468
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Ya-Wei Xu
investigator title: The chief director of department of cardiology
mesh term: Kidney Failure, Chronic
sharing ipd: No