<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/NCT01734096</url>
  </required_header>
  <id_info>
    <org_study_id>PZ00P3_121655</org_study_id>
    <nct_id>NCT01734096</nct_id>
  </id_info>
  <brief_title>Renal Response to Lower Body Negative Pressure in Pre-hypertensive States</brief_title>
  <official_title>Effect of Lower Body Negative Pressure and Angiotensin II Receptor Blockade on Renal Hemodynamic, Neuro-hormonal and Tubular Response in Pre-hypertensive States: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PD Dr. Grégoire Wuerzner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether in pre-hypertensive and hypertensive states&#xD;
      such as white coat hypertension, obesity related hypertension or resistant hypertension,&#xD;
      renal function is more sensitive to orthostatic stress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sodium excretion</measure>
    <time_frame>after one hour of lower body negative pressure</time_frame>
    <description>sodium excretion will be compared to control group (healthy volunteers) after one hour of lower negative pressure. The protocol includes 2 hours of baseline measure, one hour of lower negative pressure and 2 hours of recovery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glomerular filtration rate</measure>
    <time_frame>after one hour of lower body negative pressure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>renal plasma flow</measure>
    <time_frame>after one hour of lower body negative pressure</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <condition>White Coat Hypertension</condition>
  <condition>Resistant Hypertension</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy volunteer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>obesity group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with BMI &gt;30 Kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>white coat hypertension group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with office blood pressure &gt;140/90 mmHg and ambulatory daytime blood pressure &lt;135/85 mmHg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistant hypertension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with ambulatory blood pressure &gt; 135/85 mm Hg (day) or &gt;120/70 mm Hg (night) with 3 antihypertensive drugs with direct observance of drug taking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower body negative pressure (LBNP)</intervention_name>
    <description>Lower limbs are put in in LBNP device for one hour (-30 mbar)</description>
    <arm_group_label>Resistant hypertension</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>obesity group</arm_group_label>
    <arm_group_label>white coat hypertension group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan cilexetil</intervention_name>
    <description>candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>obesity group</arm_group_label>
    <arm_group_label>white coat hypertension group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 30 Kg/m2 (obesity group)&#xD;
&#xD;
          -  office BP &gt;140/90 and daytime ambulatory blood pressure &lt;135/85 (white coat&#xD;
             hypertension group) _daytime abpm &gt;135/85 mm Hg or nighttime abpm 120/70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergic reaction&#xD;
&#xD;
          -  Diabetes type 1 or type 2&#xD;
&#xD;
          -  History of renal artery stenosis&#xD;
&#xD;
          -  Acute illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregoire Wuerzner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Burnier, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service of nephrology and hypertension</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service of nephrology and hypertension</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>May 23, 2017</last_update_submitted>
  <last_update_submitted_qc>May 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>PD Dr. Grégoire Wuerzner</investigator_full_name>
    <investigator_title>Doctord, MD, privat docent</investigator_title>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>obesity</keyword>
  <keyword>white coat hypertension</keyword>
  <keyword>resistant hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>White Coat Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 15, 2018</submitted>
    <returned>October 23, 2018</returned>
    <submitted>August 31, 2023</submitted>
  </pending_results>
  <!-- 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/NCT01734096
org study id: PZ00P3_121655
nct id: NCT01734096
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether in pre-hypertensive and hypertensive states
      such as white coat hypertension, obesity related hypertension or resistant hypertension,
      renal function is more sensitive to orthostatic stress.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: sodium excretion
time frame: after one hour of lower body negative pressure
description: sodium excretion will be compared to control group (healthy volunteers) after one hour of lower negative pressure. The protocol includes 2 hours of baseline measure, one hour of lower negative pressure and 2 hours of recovery
measure: glomerular filtration rate
time frame: after one hour of lower body negative pressure
measure: renal plasma flow
time frame: after one hour of lower body negative pressure
arm group label: control group
arm group type: Active Comparator
description: healthy volunteer
arm group label: obesity group
arm group type: Active Comparator
description: Patients with BMI >30 Kg/m2
arm group label: white coat hypertension group
arm group type: Active Comparator
description: Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg
arm group label: Resistant hypertension
arm group type: Active Comparator
description: Patients with ambulatory blood pressure > 135/85 mm Hg (day) or >120/70 mm Hg (night) with 3 antihypertensive drugs with direct observance of drug taking.
intervention type: Other
intervention name: Lower body negative pressure (LBNP)
description: Lower limbs are put in in LBNP device for one hour (-30 mbar)
arm group label: Resistant hypertension
arm group label: control group
arm group label: obesity group
arm group label: white coat hypertension group
intervention type: Drug
intervention name: Candesartan cilexetil
description: candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group
arm group label: control group
arm group label: obesity group
arm group label: white coat hypertension group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregoire Wuerzner, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
last name: Michel Burnier, MD
role: Study Chair
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: PD Dr. Grégoire Wuerzner
investigator title: Doctord, MD, privat docent
mesh term: Hypertension
mesh term: White Coat Hypertension
mesh term: Candesartan
mesh term: Candesartan cilexetil
submitted: March 15, 2018
returned: October 23, 2018
submitted: August 31, 2023