<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/NCT02976324</url>
  </required_header>
  <id_info>
    <org_study_id>EDPCCP2016</org_study_id>
    <nct_id>NCT02976324</nct_id>
  </id_info>
  <brief_title>The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale</brief_title>
  <official_title>The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhang Xiangyu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of external diaphragmatic pacemaker on the patients with&#xD;
      chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,&#xD;
      while the other half will receive routine therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the&#xD;
      indicators include: respiratory muscle force, diaphragmatic degree of excursion and&#xD;
      thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of&#xD;
      life, pulmonary function,NT-proBNP,PaO2 and PaCO2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiopulmonary function</measure>
    <time_frame>10 days</time_frame>
    <description>six miunte walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MIP</measure>
    <time_frame>10 DAYS</time_frame>
    <description>MAX INSPIRATORY PRESSURE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Cor Pulmonale</condition>
  <arm_group>
    <arm_group_label>external diaphragmatic pacemaker group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No inervention, just receive conventional therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>external diaphragmatic pacemaker group</intervention_name>
    <description>9 counts per minute, with stimulate frequency 40 Hz</description>
    <arm_group_label>external diaphragmatic pacemaker group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of chronic cor pulmonale and admit to hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pneumothorax or mediastinal emphysema&#xD;
&#xD;
          -  active tuberculosis&#xD;
&#xD;
          -  install a cardiac pacemaker&#xD;
&#xD;
          -  acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis,&#xD;
             severe arrhythmia, severe cerebrovascular accidents.&#xD;
&#xD;
          -  pregnancies&#xD;
&#xD;
          -  end-stage patients (expected survival time less than 6 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xiangyu zhang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 20, 2017</last_update_submitted>
  <last_update_submitted_qc>October 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tongji University</investigator_affiliation>
    <investigator_full_name>Zhang Xiangyu</investigator_full_name>
    <investigator_title>Director of Intensive care medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Heart Disease</mesh_term>
  </condition_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/NCT02976324
org study id: EDPCCP2016
nct id: NCT02976324
lead sponsor: 
has dmc: Yes
This study evaluates the effect of external diaphragmatic pacemaker on the patients with
      chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,
      while the other half will receive routine therapy.
Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the
      indicators include: respiratory muscle force, diaphragmatic degree of excursion and
      thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of
      life, pulmonary function,NT-proBNP,PaO2 and PaCO2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: cardiopulmonary function
time frame: 10 days
description: six miunte walk test
measure: MIP
time frame: 10 DAYS
description: MAX INSPIRATORY PRESSURE
arm group label: external diaphragmatic pacemaker group
arm group type: Experimental
description: use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz
arm group label: control group
arm group type: No Intervention
description: No inervention, just receive conventional therapy
intervention type: Device
intervention name: external diaphragmatic pacemaker group
description: 9 counts per minute, with stimulate frequency 40 Hz
arm group label: external diaphragmatic pacemaker group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: xiangyu zhang, doctor
role: Principal Investigator
affiliation: Tongji University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Tongji University
investigator full name: Zhang Xiangyu
investigator title: Director of Intensive care medicine
mesh term: Pulmonary Heart Disease
sharing ipd: Undecided