<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/NCT03245970</url>
  </required_header>
  <id_info>
    <org_study_id>4222</org_study_id>
    <nct_id>NCT03245970</nct_id>
  </id_info>
  <brief_title>Impedance Cardiography to Decrease the Risk of Preeclampsia</brief_title>
  <official_title>Use of Impedance Cardiography to Decrease the Risk of Preeclampsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if the use of impedance cardiography can identify appropriate medications for&#xD;
      use in treating chronic hypertensive patients to decrease the risk of preeclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output&#xD;
      is occurring. The test is easy to perform and non invasive. The treatment for an elevated&#xD;
      cardiac output in pregnancy is a beta-blocker while a vasodilator is used for&#xD;
      vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make&#xD;
      the cardiovascular parameters worse, leading to no improvement in future pregnancy issues.&#xD;
      Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it&#xD;
      could potentially make the cardiovascular parameters worse.&#xD;
&#xD;
      All centers in the United States that choose to prescribe an antihypertensive medication for&#xD;
      use in pregnancy do so by trial and error, whereas impedance cardiography can help the&#xD;
      clinician choose the best medication from the start. Many pregnant patient patients have&#xD;
      chronic hypertension and this population is at increased risk for superimposed preeclampsia&#xD;
      and other pregnancy complications. The current recommendation for pregnancy is to NOT treat&#xD;
      mild hypertension because studies have not shown any benefit. These studies, have also not&#xD;
      shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in&#xD;
      pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not&#xD;
      improving the rate of superimposed preeclampsia and other pregnancy related complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator retired. Other investigators did not want to continue study.&#xD;
  </why_stopped>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Randomization to treatment or non treatment group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of preeclampsia in chronically hypertensive pregnant women</measure>
    <time_frame>2 years</time_frame>
    <description>Rates of preeclampsia in chronically hypertensive pregnant women</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Hypertension Complicating Pregnancy (Diagnosis)</condition>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.&#xD;
Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Labetalol Hydrocholoride 200 mg orally every 12 hours</intervention_name>
    <description>Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Trandate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nifedipine 60 mg orally daily</intervention_name>
    <description>Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Procardia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atenolol 25 mg daily</intervention_name>
    <description>Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Tenormin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic&#xD;
        hypertension - Not on antihypertensive medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with an allergy to antihypertensive medication or contraindication for their usage&#xD;
        such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood&#xD;
        pressure 140/90 or greater -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly Fortner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HIgh Risk Obstetrical Consultants</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atenolol</mesh_term>
    <mesh_term>Labetalol</mesh_term>
    <mesh_term>Nifedipine</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/NCT03245970
org study id: 4222
nct id: NCT03245970
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To determine if the use of impedance cardiography can identify appropriate medications for
      use in treating chronic hypertensive patients to decrease the risk of preeclampsia.
Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output
      is occurring. The test is easy to perform and non invasive. The treatment for an elevated
      cardiac output in pregnancy is a beta-blocker while a vasodilator is used for
      vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make
      the cardiovascular parameters worse, leading to no improvement in future pregnancy issues.
      Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it
      could potentially make the cardiovascular parameters worse.

      All centers in the United States that choose to prescribe an antihypertensive medication for
      use in pregnancy do so by trial and error, whereas impedance cardiography can help the
      clinician choose the best medication from the start. Many pregnant patient patients have
      chronic hypertension and this population is at increased risk for superimposed preeclampsia
      and other pregnancy complications. The current recommendation for pregnancy is to NOT treat
      mild hypertension because studies have not shown any benefit. These studies, have also not
      shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in
      pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not
      improving the rate of superimposed preeclampsia and other pregnancy related complications.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization to treatment or non treatment group
primary purpose: Prevention
masking: None (Open Label)
measure: Rates of preeclampsia in chronically hypertensive pregnant women
time frame: 2 years
description: Rates of preeclampsia in chronically hypertensive pregnant women
arm group label: Treatment Arm
arm group type: Active Comparator
description: Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily
arm group label: Non Treatment
arm group type: No Intervention
description: Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.
intervention type: Drug
intervention name: Labetalol Hydrocholoride 200 mg orally every 12 hours
description: Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
arm group label: Treatment Arm
other name: Trandate
intervention type: Drug
intervention name: Nifedipine 60 mg orally daily
description: Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
arm group label: Treatment Arm
other name: Procardia
intervention type: Drug
intervention name: Atenolol 25 mg daily
description: Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
arm group label: Treatment Arm
other name: Tenormin
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 51 Years
healthy volunteers: No
last name: Kimberly Fortner, MD
role: Principal Investigator
affiliation: University of Tennessee Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Pregnancy Complications
mesh term: Atenolol
mesh term: Labetalol
mesh term: Nifedipine
sharing ipd: No