<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/NCT01682304</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC611</org_study_id>
    <nct_id>NCT01682304</nct_id>
  </id_info>
  <brief_title>Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension</brief_title>
  <official_title>Observational Study of Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preliminary data from the investigator's lab identified novel patterns of differential DNA&#xD;
      methylation in genes regulating cardiovascular and metabolic function in blood from women&#xD;
      during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in the&#xD;
      third trimester. Further, common patterns of differential DNA methylation were found in the&#xD;
      common genes from placental tissue at time of birth in the same women after diagnosis with&#xD;
      PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension may&#xD;
      also underlie the development of chronic hypertension years after.&#xD;
&#xD;
      It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the&#xD;
      mechanism by which chronic hypertension develops in these women remote from pregnancy nor is&#xD;
      it known if hypertension remote from PE is as responsive to therapeutic treatment of&#xD;
      hypertension compared to women who develop hypertension without history of PE. The&#xD;
      investigators plan to objectively test the central hypothesis and attain the objective of&#xD;
      this project&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women comprise 51% of the total heart disease deaths in the United States (NC with an&#xD;
      estimated economic cost expected to climb to more than $258 billion. Hypertension, a&#xD;
      prevalent manifestation of early cardiovascular disease, is a silent condition that&#xD;
      contributes to significant adverse health consequences. Preeclampsia (PE), a form of&#xD;
      pregnancy-induced hypertension diagnosed in the second half of pregnancy, is now established&#xD;
      as a non-modifiable risk factor for future development of hypertension. As PE carries a&#xD;
      familial risk for future development of PE in female offspring, the implications of increased&#xD;
      risk for PE-associated future development of chronic hypertension further compounds the&#xD;
      significance of this unique cardiovascular risk. This raises an important health concern,&#xD;
      though little is known about the mechanisms underlying risk of PE-associated future chronic&#xD;
      hypertension. As epigenetic patterns of DNA methylation are associated with transfer across&#xD;
      generations and are known to be dysregulated in PE, we propose to test the central hypothesis&#xD;
      that differential DNA methylation patterns in key cardiovascular genes identified in women&#xD;
      with PE serve as a biomarker and predictor for therapeutic responsiveness for the remote&#xD;
      diagnosis and prognosis of chronic hypertension, respectively. Therefore, the purpose of this&#xD;
      study is to identify distinct epigenetic patterns of DNA methylation associated with&#xD;
      preeclampsia (PE) that underlie the future development of hypertension and to determine the&#xD;
      implication on responses to moderators and therapeutic interventions in the management of&#xD;
      chronic hypertension.Univariate analysis of variance will be used to test associations&#xD;
      between DNA methylation in genes and chronic hypertension among women with and without a&#xD;
      history of preeclampsia. We will use multiple linear regression to examine differences in&#xD;
      treatment responses to high blood pressure based on DNA methylation patterns in candidate&#xD;
      cardiovascular genes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DNA methylation pattern</measure>
    <time_frame>age 30-65</time_frame>
    <description>Determine DNA methylatiion patterns in women with hypertension who have/have not had a prior diagnosis of preeclampsia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>aged 30-65</time_frame>
    <description>Determine differences in vascular function among women aged 30-65, diagnosed with hypertension and who have/have not had a prior diagnosis of preeclampsia</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Preeclampsia</condition>
  <condition>Hypertension</condition>
  <condition>Pregnancy Induced Hypertension</condition>
  <arm_group>
    <arm_group_label>History of Preeclampsia</arm_group_label>
    <description>Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum and peripheral blood will be collected for DNA extraction and epigenetic analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Females diagnosed with chronic hypertension with a prior pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female gender&#xD;
&#xD;
          -  history of prior pregnancy&#xD;
&#xD;
          -  diagnosis of chronic hypertension&#xD;
&#xD;
          -  current treatment of chronic hypertension&#xD;
&#xD;
          -  age 30 - 50 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of comorbid conditions that influence cardiovascular health (SLE, congenital&#xD;
             cardiac anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy M Anderson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Cindy Anderson</investigator_full_name>
    <investigator_title>PhD, WHNP-BC, FAAN</investigator_title>
  </responsible_party>
  <keyword>preeclampsia</keyword>
  <keyword>hypertension</keyword>
  <keyword>blood pressure</keyword>
  <keyword>pregnancy induced hypertension</keyword>
  <keyword>chronic hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <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/NCT01682304
org study id: GFHNRC611
nct id: NCT01682304
lead sponsor: 
has dmc: No
Preliminary data from the investigator's lab identified novel patterns of differential DNA
      methylation in genes regulating cardiovascular and metabolic function in blood from women
      during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in the
      third trimester. Further, common patterns of differential DNA methylation were found in the
      common genes from placental tissue at time of birth in the same women after diagnosis with
      PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension may
      also underlie the development of chronic hypertension years after.

      It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the
      mechanism by which chronic hypertension develops in these women remote from pregnancy nor is
      it known if hypertension remote from PE is as responsive to therapeutic treatment of
      hypertension compared to women who develop hypertension without history of PE. The
      investigators plan to objectively test the central hypothesis and attain the objective of
      this project
Women comprise 51% of the total heart disease deaths in the United States (NC with an
      estimated economic cost expected to climb to more than $258 billion. Hypertension, a
      prevalent manifestation of early cardiovascular disease, is a silent condition that
      contributes to significant adverse health consequences. Preeclampsia (PE), a form of
      pregnancy-induced hypertension diagnosed in the second half of pregnancy, is now established
      as a non-modifiable risk factor for future development of hypertension. As PE carries a
      familial risk for future development of PE in female offspring, the implications of increased
      risk for PE-associated future development of chronic hypertension further compounds the
      significance of this unique cardiovascular risk. This raises an important health concern,
      though little is known about the mechanisms underlying risk of PE-associated future chronic
      hypertension. As epigenetic patterns of DNA methylation are associated with transfer across
      generations and are known to be dysregulated in PE, we propose to test the central hypothesis
      that differential DNA methylation patterns in key cardiovascular genes identified in women
      with PE serve as a biomarker and predictor for therapeutic responsiveness for the remote
      diagnosis and prognosis of chronic hypertension, respectively. Therefore, the purpose of this
      study is to identify distinct epigenetic patterns of DNA methylation associated with
      preeclampsia (PE) that underlie the future development of hypertension and to determine the
      implication on responses to moderators and therapeutic interventions in the management of
      chronic hypertension.Univariate analysis of variance will be used to test associations
      between DNA methylation in genes and chronic hypertension among women with and without a
      history of preeclampsia. We will use multiple linear regression to examine differences in
      treatment responses to high blood pressure based on DNA methylation patterns in candidate
      cardiovascular genes.
observational model: Case-Control
time perspective: Prospective
measure: DNA methylation pattern
time frame: age 30-65
description: Determine DNA methylatiion patterns in women with hypertension who have/have not had a prior diagnosis of preeclampsia
measure: Vascular function
time frame: aged 30-65
description: Determine differences in vascular function among women aged 30-65, diagnosed with hypertension and who have/have not had a prior diagnosis of preeclampsia
arm group label: History of Preeclampsia
description: Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia
Sputum and peripheral blood will be collected for DNA extraction and epigenetic analyses.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cindy M Anderson, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Cindy Anderson
investigator title: PhD, WHNP-BC, FAAN
mesh term: Pre-Eclampsia
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension