<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/NCT02243514</url>
  </required_header>
  <id_info>
    <org_study_id>US-RNRE</org_study_id>
    <secondary_id>NSFC81370440</secondary_id>
    <nct_id>NCT02243514</nct_id>
  </id_info>
  <brief_title>Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases</brief_title>
  <official_title>Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these&#xD;
      conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an&#xD;
      important part in the autonomic nervous system regulation, especially in cardiovascular&#xD;
      system, the modulation of the renal nerves used as a therapeutic strategy has been researched&#xD;
      across the world. The purpose of this study is to evaluate and quantify the morphology&#xD;
      changes in different diseases, make the modulation therapy more selective and effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People eligible for this study will be divided into 4 groups according to the eligibility&#xD;
      criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure&#xD;
      Group and Control Group), about 15 objects for each, totally 60 objects are going to be&#xD;
      recruited.&#xD;
&#xD;
      Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma&#xD;
      catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An&#xD;
      intravascular ultrasound examination will be taken after all of these have been done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number increase of Renal nerves in patients with sympathetic over-activity diseases</measure>
    <time_frame>A duration of the whole research stage, an expected average of 1/2 year</time_frame>
    <description>Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area increase of Renal nerves in patients with sympathetic over-activity diseases</measure>
    <time_frame>A duration of the whole research stage, an expected average of 1/2 year</time_frame>
    <description>Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.</measure>
    <time_frame>A duration of the whole research stage, an expected average of 1/2 year</time_frame>
    <description>Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²);&#xD;
Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²);&#xD;
Total area of the renal nerve/Total renal artery area: percentage (%);&#xD;
Total area of the renal nerve/Total renal arterial wall area: percentage (%);</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure</measure>
    <time_frame>Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours</time_frame>
    <description>Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including:&#xD;
Emerging renal artery dissection;&#xD;
Emerging renal artery stenosis, which will not improve by the intravascular injection of nitroglycerin;&#xD;
Emerging renal artery rupture or perforate;&#xD;
Contrast-induced nephropathy&#xD;
Any other complications related to this intervention procedure, such as catheter breakage, infection, hematoma ect.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hypertension</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Resistant hypertension</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Essential hypertension</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic heart failure</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, urine, stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients who are going to take a vascular interventional examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Resistant hypertension group&#xD;
&#xD;
               -  blood pressure remains above goal in spite of the concurrent use of three or more&#xD;
                  anti-hypertensive agents(including a diuretic) at adequate doses.&#xD;
&#xD;
               -  agrees to have the study procedure(s) performed and additional procedures and&#xD;
                  evaluations&#xD;
&#xD;
          2. Essential hypertension group&#xD;
&#xD;
               -  systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, or&#xD;
                  current use of anti-hypertensive medication with a normal blood pressure or mean&#xD;
                  ambulatory blood pressure during the 24-hour≥130/80 mmHg.&#xD;
&#xD;
               -  not resistant to pharmacotherapy.&#xD;
&#xD;
               -  agrees to have the study procedure(s) performed and additional procedures and&#xD;
                  evaluations&#xD;
&#xD;
          3. Chronic heart failure group&#xD;
&#xD;
               -  New York Heart Association class II-III symptoms, or American College of&#xD;
                  Cardiology(ACC) / American Heart Association(AHA) heart failure classification&#xD;
                  B-C class of chronic heart failure.&#xD;
&#xD;
               -  currently or prior have the signs of heart failure, such as elevated jugular&#xD;
                  venous pressure, peripheral edema, pulmonary crepitations, ect.&#xD;
&#xD;
               -  Systolic left ventricular dysfunction as assessed by echocardiogram with left&#xD;
                  ventricular ejection fraction &lt; 40%.&#xD;
&#xD;
               -  agrees to have the study procedure(s) performed and additional procedures and&#xD;
                  evaluations&#xD;
&#xD;
          4. Control group&#xD;
&#xD;
               -  no history of arterial hypertension, heart failure and diabetes&#xD;
&#xD;
               -  going to take a vascular interventional examination during hospitalization&#xD;
&#xD;
               -  agrees to have the study procedure(s) performed and additional procedures and&#xD;
                  evaluations&#xD;
&#xD;
        All patients have full capacity for civil conduct and agree to sign the Medical Informed&#xD;
        Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hemodynamically or anatomically significant renal artery stenosis.&#xD;
&#xD;
          -  renal artery variation.&#xD;
&#xD;
          -  renal artery diameter &lt; 4 mm, trunk length &lt; 20 mm.&#xD;
&#xD;
          -  secondary hypertension with known causes and pseudo-hypertension.&#xD;
&#xD;
          -  has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular&#xD;
             accident within 6 months.&#xD;
&#xD;
          -  has an implantable cardioverter defibrillator (ICD) or pacemaker.&#xD;
&#xD;
          -  requires respiratory support.&#xD;
&#xD;
          -  is pregnant or planning to be pregnant.&#xD;
&#xD;
          -  cardiovascular diseases with sever hemodynamic disorder.&#xD;
&#xD;
          -  type 1 diabetes mellitus.&#xD;
&#xD;
          -  currently enrolled in another investigational drug or device trial.&#xD;
&#xD;
          -  civil disability or limited capacity for civil conduct.&#xD;
&#xD;
          -  other conditions researchers considered unsuitable for enrolled in the trial.&#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>Jing Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Huang, MD</last_name>
    <phone>0086-13508312022</phone>
    <email>huangjing@cqmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The 2nd Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Huang, MD</last_name>
      <phone>0086-13508312022</phone>
      <email>huangjing@cqmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Jing Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.</citation>
    <PMID>24678939</PMID>
  </reference>
  <reference>
    <citation>D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.</citation>
    <PMID>24292688</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>October 22, 2014</last_update_submitted>
  <last_update_submitted_qc>October 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Jing Huang</investigator_full_name>
    <investigator_title>Professor and Vice Director, Department of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Heart failure</keyword>
  <keyword>Sympathetic hyperactivity</keyword>
  <keyword>Renal nerve</keyword>
  <keyword>Remodeling</keyword>
  <keyword>Nerve remodeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Failure</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/NCT02243514
org study id: US-RNRE
secondary id: NSFC81370440
nct id: NCT02243514
lead sponsor: 
has dmc: Yes
Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these
      conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an
      important part in the autonomic nervous system regulation, especially in cardiovascular
      system, the modulation of the renal nerves used as a therapeutic strategy has been researched
      across the world. The purpose of this study is to evaluate and quantify the morphology
      changes in different diseases, make the modulation therapy more selective and effective.
People eligible for this study will be divided into 4 groups according to the eligibility
      criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure
      Group and Control Group), about 15 objects for each, totally 60 objects are going to be
      recruited.

      Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma
      catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An
      intravascular ultrasound examination will be taken after all of these have been done.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Number increase of Renal nerves in patients with sympathetic over-activity diseases
time frame: A duration of the whole research stage, an expected average of 1/2 year
description: Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;
measure: Area increase of Renal nerves in patients with sympathetic over-activity diseases
time frame: A duration of the whole research stage, an expected average of 1/2 year
description: Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);
measure: The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
time frame: A duration of the whole research stage, an expected average of 1/2 year
description: Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²);
Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²);
Total area of the renal nerve/Total renal artery area: percentage (%);
Total area of the renal nerve/Total renal arterial wall area: percentage (%);
measure: Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
time frame: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
description: Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including:
Emerging renal artery dissection;
Emerging renal artery stenosis, which will not improve by the intravascular injection of nitroglycerin;
Emerging renal artery rupture or perforate;
Contrast-induced nephropathy
Any other complications related to this intervention procedure, such as catheter breakage, infection, hematoma ect.
arm group label: Resistant hypertension
arm group label: Essential hypertension
arm group label: Chronic heart failure
arm group label: Control
whole blood, urine, stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jing Huang, MD
role: Principal Investigator
affiliation: Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University
last name: Jing Huang, MD
phone: 0086-13508312022
email: huangjing@cqmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PMID: 24678939
citation: D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.
PMID: 24292688
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital of Chongqing Medical University
investigator full name: Jing Huang
investigator title: Professor and Vice Director, Department of Cardiology
mesh term: Hypertension
mesh term: Heart Failure