<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/NCT03758196</url>
  </required_header>
  <id_info>
    <org_study_id>HenanICE201802</org_study_id>
    <nct_id>NCT03758196</nct_id>
  </id_info>
  <brief_title>Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）</brief_title>
  <official_title>Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henan Institute of Cardiovascular Epidemiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henan Institute of Cardiovascular Epidemiology</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As one of the most common chronic diseases,The adult prevalence of hypertension is&#xD;
      approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation&#xD;
      from the intima of renal artery has emerged as a potential treatment for resistant&#xD;
      hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there&#xD;
      is no report on renal sympathetic denervation from the adventitia of renal artery.This study&#xD;
      is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy&#xD;
      of radiofrequency ablation of the renal artery from the adventitia on the basis of&#xD;
      laparoscopic techniques for patients with resistant hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and&#xD;
      efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of&#xD;
      laparoscopic techniques for patients with resistant hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 31, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.</measure>
    <time_frame>Baseline to 1 months,3 months,6 months,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge</measure>
    <time_frame>Baseline to 1 months,3 months,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge</measure>
    <time_frame>Baseline to 1 months,3 months,6 months,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge</measure>
    <time_frame>Baseline to 1 months,3 months,6 months,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal function in 1,3,6,12 months after discharge</measure>
    <time_frame>Baseline to 1 months,3 months,6 months,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The surgical complications of renal artery perforation,such as stenosis,and dissection associated with radiofrequency surgery.And major cardiovascular and cerebrovascular events ,including cardiac death,stroke and nonfatal- myocardial infarction.</measure>
    <time_frame>Baseline to 6 months,12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Resistant Hypertension</condition>
  <arm_group>
    <arm_group_label>Renal sympathetic denervation from the adventitia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>optimized medication regimen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>optimized medication regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radiofrequency ablation instruments</intervention_name>
    <description>Renal Sympathetic Denervation from the adventitia of renal artery</description>
    <arm_group_label>Renal sympathetic denervation from the adventitia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.18 years old ≤ age ≤ 65 years old; 2.Patients with clear diagnosis of resistant&#xD;
        hypertension prior to enrollment：On the basis of improving lifestyle, a reasonable and&#xD;
        tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for&#xD;
        more than one month, clinic SBP≥140mmHg or (and) DBP≥90mmHg, 24 hours dynamic Blood&#xD;
        pressure monitoring SBP&gt;130mmHg or (and) DBP&gt;80mmHg; 3.Estimated GFR (eGFR) ≥&#xD;
        60ml/min/1.73m2; 4.The patient or his legal guardian has signed the informed consent;&#xD;
        5.Patients who are willing and able to perform follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with secondary hypertension caused by any known cause;&#xD;
&#xD;
          2. pregnant or planning to be pregnant;&#xD;
&#xD;
          3. Patients with renal artery diameter &lt;4mm or length &lt;20mm;&#xD;
&#xD;
          4. Patients with renal artery abnormalities include: hemodynamic or anatomically&#xD;
             significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon&#xD;
             angioplasty or stenting;renal involvement on either side Multiple renal arteries,and&#xD;
             renal arteries supply &lt;75% of the kidneys;abnormal renal artery anatomy,such as tumor&#xD;
             expansion;&#xD;
&#xD;
          5. Patients with cardiovascular instability factors includes:acute myocardial infarction&#xD;
             within six months,unstable angina or cerebrovascular disease;heart valve disease with&#xD;
             significantly altered hemodynamics;&#xD;
&#xD;
          6. Patients with other serious organic diseases;&#xD;
&#xD;
          7. Patients participated in other studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuanyu Gao, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiguang Huang, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yahui Liu, Bachelor</last_name>
    <phone>+86 18317898825</phone>
    <email>1182600873@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chuanyu Gao, Dr.</last_name>
    <phone>+86 13937165590</phone>
    <email>gaocy6802@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhengzhou university People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chuanyu Gao, Dr</last_name>
      <phone>+86 13937165590</phone>
      <email>gaocy6802@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal sympathetic denervation</keyword>
  <keyword>resistant hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03758196
org study id: HenanICE201802
nct id: NCT03758196
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
As one of the most common chronic diseases,The adult prevalence of hypertension is
      approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation
      from the intima of renal artery has emerged as a potential treatment for resistant
      hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there
      is no report on renal sympathetic denervation from the adventitia of renal artery.This study
      is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy
      of radiofrequency ablation of the renal artery from the adventitia on the basis of
      laparoscopic techniques for patients with resistant hypertension.
This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and
      efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of
      laparoscopic techniques for patients with resistant hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
time frame: Baseline to 6 months
measure: Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.
time frame: Baseline to 1 months,3 months,6 months,12 months
measure: Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge
time frame: Baseline to 6 months
measure: Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge
time frame: Baseline to 1 months,3 months,12 months
measure: Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge
time frame: Baseline to 1 months,3 months,6 months,12 months
measure: Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge
time frame: Baseline to 1 months,3 months,6 months,12 months
measure: renal function in 1,3,6,12 months after discharge
time frame: Baseline to 1 months,3 months,6 months,12 months
measure: The surgical complications of renal artery perforation,such as stenosis,and dissection associated with radiofrequency surgery.And major cardiovascular and cerebrovascular events ,including cardiac death,stroke and nonfatal- myocardial infarction.
time frame: Baseline to 6 months,12 months
arm group label: Renal sympathetic denervation from the adventitia
arm group type: Experimental
description: Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen
arm group label: optimized medication regimen
arm group type: No Intervention
description: optimized medication regimen
intervention type: Device
intervention name: Radiofrequency ablation instruments
description: Renal Sympathetic Denervation from the adventitia of renal artery
arm group label: Renal sympathetic denervation from the adventitia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chuanyu Gao, Dr.
role: Principal Investigator
affiliation: Henan Provincial People's Hospital
last name: Jiguang Huang, Dr.
role: Principal Investigator
affiliation: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension
last name: Yahui Liu, Bachelor
phone: +86 18317898825
email: 1182600873@qq.com
last name: Chuanyu Gao, Dr.
phone: +86 13937165590
email: gaocy6802@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hypertension