<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/NCT02210923</url>
  </required_header>
  <id_info>
    <org_study_id>NL3770006813</org_study_id>
    <nct_id>NCT02210923</nct_id>
  </id_info>
  <brief_title>Effect Baroreflex Activation Therapy on the Carotid Body</brief_title>
  <official_title>Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CVRx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in&#xD;
      blood pressure in patients with resistant hypertension. Since the activation electrodes are&#xD;
      implanted at the level of the carotid sinus, it is conceivable that the nearby located&#xD;
      carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid&#xD;
      chemoreceptors not only raises respiration, but it also increases sympathetic activity which&#xD;
      may in part counteract the effects of BAT. The aim of the present study is to investigate&#xD;
      whether there is evidence for concomitant carotid chemoreflex activation during BAT. We&#xD;
      hypothesized that there is no clinically relevant co-activation of the carotid body&#xD;
      chemoreceptors during BAT in patients with resistant hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arterial CO2 (PaCO2) during baroreflex activation therapy</measure>
    <time_frame>6 times during different electrical activation settings within one hour</time_frame>
    <description>During one hour several device activation settings will be programmed at random. During each device setting we will collect arterial blood samples to check for PaCO2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in end-tidal CO2 during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>The change in cardiovascular variables will be analyzed during each device activation setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory rate during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in expiration time during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>The change in cardiovascular variables will be analyzed during each device activation setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peripheral vascular resistance during baroreflex activation therapy</measure>
    <time_frame>1 - 1.25 hour</time_frame>
    <description>The change in cardiovascular variables will be analyzed during each device activation setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expiratory volume-1 second (FEV1) before and after turning off the device</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hypertension Resistant To Conventional Therapy</condition>
  <condition>Baroreflex</condition>
  <condition>Carotid Body</condition>
  <arm_group>
    <arm_group_label>Resistant hypertensive patients with Rheos system</arm_group_label>
    <description>We will program 6 electrical device activation setting twice in a random order to see what happens with the aforementioned respiratory and cardiovascular variables. The following electrical settings will be programmed for 4 minutes each setting:&#xD;
20 Hz, 3 Volts, 480 microseconds&#xD;
20 Hz, 6 Volts, 480 microseconds&#xD;
50 Hz, 3 Volts, 480 microseconds&#xD;
50 Hz, 6 Volts, 480 microseconds&#xD;
90 Hz, 3 Volts, 480 microseconds&#xD;
90 Hz, 6 Volts, 480 microseconds</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Arterial blood for analysis of PaCO2, PaO2 and pH&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects implanted with a BAT system will be invited to participate in this study. These&#xD;
        are patients who were enrolled in the DEBuT-HET and Rheos Pivotal Trial and have given&#xD;
        their permission to be approached for follow-up studies. Subjects are all &gt;21 years of age&#xD;
        and were all known with a blood pressure ≥160/90 mmHg despite optimal antihypertensive&#xD;
        therapy before receiving BAT. It is essential to have the Rheos® device implanted to enable&#xD;
        participation in this study, as we want to investigate the effect of electrical carotid&#xD;
        sinus activation on the carotid body chemoreflex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be currently implanted with Rheos system and have completed the 13-month follow-up&#xD;
             period.&#xD;
&#xD;
          -  Be on stable anti-hypertensive therapy for at least 4 weeks prior to inclusion, where&#xD;
             stable is defined as no changes in medications or dosage of medications.&#xD;
&#xD;
          -  Have at least one functional carotid baroreflex activation electrode.&#xD;
&#xD;
          -  Have signed and approved informed consent form for participation in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myocardial infarction (MI) or cerebral vascular accident (CVA) within the past 90&#xD;
             days, or subject is still unstable from a prior MI or CVA that occurred more than 90&#xD;
             days ago.&#xD;
&#xD;
          -  Are unable or unwilling to comply with the protocol requirements of this study.&#xD;
&#xD;
          -  Diagnosed with severe chronic obstructive lung disease (COPD/asthma GOLD stadium III&#xD;
             and IV).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abraham Kroon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Teba Alnima, MD</last_name>
    <phone>003143 3875367</phone>
    <email>teba.alnima@mumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maastricht University Medical Center+</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teba Alnima, MD</last_name>
      <phone>0031 43 3875367</phone>
      <email>teba.alnima@mumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://cvrx.com</url>
    <description>Overall description of the device and related safety and efficacy results</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baroreflex</keyword>
  <keyword>Electrical stimulation</keyword>
  <keyword>Carotid body</keyword>
  <keyword>Chemoreceptors</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/NCT02210923
org study id: NL3770006813
nct id: NCT02210923
lead sponsor: 
collaborator: 
has dmc: Yes
Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in
      blood pressure in patients with resistant hypertension. Since the activation electrodes are
      implanted at the level of the carotid sinus, it is conceivable that the nearby located
      carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid
      chemoreceptors not only raises respiration, but it also increases sympathetic activity which
      may in part counteract the effects of BAT. The aim of the present study is to investigate
      whether there is evidence for concomitant carotid chemoreflex activation during BAT. We
      hypothesized that there is no clinically relevant co-activation of the carotid body
      chemoreceptors during BAT in patients with resistant hypertension.
observational model: Cohort
time perspective: Prospective
measure: Change in arterial CO2 (PaCO2) during baroreflex activation therapy
time frame: 6 times during different electrical activation settings within one hour
description: During one hour several device activation settings will be programmed at random. During each device setting we will collect arterial blood samples to check for PaCO2.
measure: Change in end-tidal CO2 during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
measure: Change in blood pressure during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: The change in cardiovascular variables will be analyzed during each device activation setting
measure: Change in respiratory rate during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
measure: Change in expiration time during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
measure: Change in heart rate during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: The change in cardiovascular variables will be analyzed during each device activation setting
measure: Change in peripheral vascular resistance during baroreflex activation therapy
time frame: 1 - 1.25 hour
description: The change in cardiovascular variables will be analyzed during each device activation setting
measure: Change in forced expiratory volume-1 second (FEV1) before and after turning off the device
time frame: 2 hours
arm group label: Resistant hypertensive patients with Rheos system
description: We will program 6 electrical device activation setting twice in a random order to see what happens with the aforementioned respiratory and cardiovascular variables. The following electrical settings will be programmed for 4 minutes each setting:
20 Hz, 3 Volts, 480 microseconds
20 Hz, 6 Volts, 480 microseconds
50 Hz, 3 Volts, 480 microseconds
50 Hz, 6 Volts, 480 microseconds
90 Hz, 3 Volts, 480 microseconds
90 Hz, 6 Volts, 480 microseconds
Arterial blood for analysis of PaCO2, PaO2 and pH
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Abraham Kroon, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Teba Alnima, MD
phone: 003143 3875367
email: teba.alnima@mumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
url: http://cvrx.com
description: Overall description of the device and related safety and efficacy results
responsible party type: Sponsor
mesh term: Hypertension