<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/NCT02220335</url>
  </required_header>
  <id_info>
    <org_study_id>20140618</org_study_id>
    <nct_id>NCT02220335</nct_id>
  </id_info>
  <brief_title>Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure</brief_title>
  <acronym>PADN-5</acronym>
  <official_title>Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A number of 100 patients with pulmonary hypertension associated with the left Heart failure&#xD;
      scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either&#xD;
      PADN or control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure patients must have completed the right heart catheterization. All the patients&#xD;
      accepted the optimal medical therapies,including diuretics, Nitrate esters, β-blockers, ACE&#xD;
      inhibitors or receptor blocker aldosterone antagonists and/or digoxin).The patients of&#xD;
      pulmonary hypertension are defined into two groups: &quot;passive&quot; pulmonary hypertension(mPAP≥25&#xD;
      mmHg, PCWP&gt;15 mmHg and pulmonary vascular resistance&lt;3 woods unit) increase due to backward&#xD;
      transmission of increased left ventricular filling pressure, &quot;reactive&quot; pulmonary&#xD;
      hypertension (mPAP≥25 mmHg, PCWP&gt;15 mmHg and pulmonary vascular resistance &gt;3 woods unit)&#xD;
      increase in resistance due to either pulmonary vasoconstriction or structural changes in the&#xD;
      pulmonary vasculature.&#xD;
&#xD;
      All the &quot;reactive&quot; pulmonary hypertension patients are eligible for the randomized study in&#xD;
      PADN group or control group according to the computer generated random table.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2014</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 16, 2018</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-min-walk distance increase</measure>
    <time_frame>6 months</time_frame>
    <description>The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary vascular resistance</measure>
    <time_frame>6 months</time_frame>
    <description>Measure pulmonary vascular resistance using 2D doppler echocardiogram w/definity. Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Accuracy of pulmonary embolism</measure>
    <time_frame>6 months</time_frame>
    <description>The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following:&#xD;
new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;&#xD;
new perfusion defect of at least 75% on V/Q lung scan;&#xD;
inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography&#xD;
Fatal PE is:&#xD;
PE based on objective diagnostic testing or autopsy or&#xD;
death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Pulmonary Arterial Denervation (PADN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes were tightly in contact with the endovascular surface. About four to eight ablations at 10 W for 60 seconds each were performed in ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary arterial denervation</intervention_name>
    <description>Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.</description>
    <arm_group_label>Pulmonary Arterial Denervation (PADN)</arm_group_label>
    <other_name>PADN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.</description>
    <arm_group_label>Pulmonary Arterial Denervation (PADN)</arm_group_label>
    <arm_group_label>Standard treatment</arm_group_label>
    <other_name>Diuretics</other_name>
    <other_name>Nitrate esters</other_name>
    <other_name>β-blockers</other_name>
    <other_name>ACE inhibitors or receptor blockers aldosterone antagonists</other_name>
    <other_name>Digoxin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18yr&#xD;
&#xD;
          -  &quot;Reactive&quot;Pulmonary Hypertension in Left Heart Failure: mPAP≥25 mmHg, PCWP&gt;15 mmHg and&#xD;
             pulmonary vascular resistance (PVR) [The PVR =(mPAP-PCWP)/ carbon monoxide]&gt;3.0 woods&#xD;
             unit&#xD;
&#xD;
          -  Voluntary acceptance of all follow-up assessment of program requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO group I, III, IV, V pulmonary artery hypertension&#xD;
&#xD;
          -  Severe Renal dysfunction (Ccr&lt;30 ml/min)&#xD;
&#xD;
          -  Blood platelet count&lt;100,000/L&#xD;
&#xD;
          -  Expected life span&lt;12-month&#xD;
&#xD;
          -  In pregnancy&#xD;
&#xD;
          -  Systematical inflammation&#xD;
&#xD;
          -  Malignant cancer(s)&#xD;
&#xD;
          -  Tricuspid valve stenosis, Supra-pulmonary valve stenosis&#xD;
&#xD;
          -  Allergic to studied drugs or metal materials&#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>Shaoliang Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Shaoliang Chen</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </responsible_party>
  <keyword>pulmonary hypertension</keyword>
  <keyword>pulmonary arterial denervation</keyword>
  <keyword>left heart failure</keyword>
  <keyword>6-min walk distance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Diuretics</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
    <mesh_term>Mineralocorticoid Receptor Antagonists</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/NCT02220335
org study id: 20140618
nct id: NCT02220335
lead sponsor: 
has dmc: Yes
A number of 100 patients with pulmonary hypertension associated with the left Heart failure
      scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either
      PADN or control group.
Heart failure patients must have completed the right heart catheterization. All the patients
      accepted the optimal medical therapies,including diuretics, Nitrate esters, β-blockers, ACE
      inhibitors or receptor blocker aldosterone antagonists and/or digoxin).The patients of
      pulmonary hypertension are defined into two groups: "passive" pulmonary hypertension(mPAP≥25
      mmHg, PCWP>15 mmHg and pulmonary vascular resistance<3 woods unit) increase due to backward
      transmission of increased left ventricular filling pressure, "reactive" pulmonary
      hypertension (mPAP≥25 mmHg, PCWP>15 mmHg and pulmonary vascular resistance >3 woods unit)
      increase in resistance due to either pulmonary vasoconstriction or structural changes in the
      pulmonary vasculature.

      All the "reactive" pulmonary hypertension patients are eligible for the randomized study in
      PADN group or control group according to the computer generated random table.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 6-min-walk distance increase
time frame: 6 months
description: The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.
measure: Pulmonary vascular resistance
time frame: 6 months
description: Measure pulmonary vascular resistance using 2D doppler echocardiogram w/definity. Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.
measure: Accuracy of pulmonary embolism
time frame: 6 months
description: The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following:
new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;
new perfusion defect of at least 75% on V/Q lung scan;
inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography
Fatal PE is:
PE based on objective diagnostic testing or autopsy or
death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out.
arm group label: Pulmonary Arterial Denervation (PADN)
arm group type: Experimental
description: Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes were tightly in contact with the endovascular surface. About four to eight ablations at 10 W for 60 seconds each were performed in ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.
arm group label: Standard treatment
arm group type: Active Comparator
description: Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.
intervention type: Procedure
intervention name: Pulmonary arterial denervation
description: Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
arm group label: Pulmonary Arterial Denervation (PADN)
other name: PADN
intervention type: Drug
intervention name: Standard treatment
description: Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
arm group label: Pulmonary Arterial Denervation (PADN)
arm group label: Standard treatment
other name: Diuretics
other name: Nitrate esters
other name: β-blockers
other name: ACE inhibitors or receptor blockers aldosterone antagonists
other name: Digoxin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaoliang Chen, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Shaoliang Chen
investigator title: Vice President
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Heart Failure
mesh term: Digoxin
mesh term: Diuretics
mesh term: Angiotensin-Converting Enzyme Inhibitors
mesh term: Mineralocorticoid Receptor Antagonists
sharing ipd: No