<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/NCT03760562</url>
  </required_header>
  <id_info>
    <org_study_id>16_146H</org_study_id>
    <nct_id>NCT03760562</nct_id>
  </id_info>
  <brief_title>The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases</brief_title>
  <official_title>The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases in England.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008,&#xD;
      it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3&#xD;
      months) glucocorticoids, rising to 3% in women aged over 80 years.&#xD;
&#xD;
      The aim of the project is to investigate the dose-response estimates of risk of high blood&#xD;
      pressure associated with oral glucocorticoids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension is a chronic condition which affects 1 in 5 of the world adult population. The&#xD;
      cause of hypertension is unknown in about 95% of patients, whilst 5% are secondary to&#xD;
      underlying adrenal disorders or other identifiable causes.&#xD;
&#xD;
      Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008,&#xD;
      it was estimated that 0.8% of the UK adult population had used long-term (≥ 3 months)&#xD;
      glucocorticoids, rising to 3% in women aged over 80 years. Glucocorticoids are effective in&#xD;
      controlling underlying chronic inflammatory disease in majority of cases. However, their&#xD;
      continuous use can result in a variety of complications, including hypertension.Although it&#xD;
      is acknowledged that excess cortisol is a leading cause of hypertension, the role of&#xD;
      exogenous glucocorticoids is less known.&#xD;
&#xD;
      The aim of the project is to investigate the dose-response estimates of risk of high blood&#xD;
      pressure associated with oral glucocorticoids.&#xD;
&#xD;
      This is a retrospective cohort study of people diagnosed with at least one of six chronic&#xD;
      inflammatory diseases (polymyalgia rheumatica, giant cell arteritis, systemic lupus&#xD;
      erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease). This study&#xD;
      will be based on the analysis of existing primary care health records routinely collected,&#xD;
      linked to hospital and mortality data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1998</start_date>
  <completion_date type="Actual">September 30, 2015</completion_date>
  <primary_completion_date type="Actual">January 30, 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glucocorticoid-related hypertension</measure>
    <time_frame>18 years</time_frame>
    <description>Number of patients with incident hypertension</description>
  </primary_outcome>
  <enrollment type="Actual">111804</enrollment>
  <condition>Hypertension</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoids</intervention_name>
    <description>Oral Glucocorticoids.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients registered in Clinical Practice Research Datalink (CPRD) who were eligible for&#xD;
        data linkage and had been diagnosed with at least one of six chronic inflammatory diseases&#xD;
        (inflammatory bowel diseases, systemic lupus erythematosus, polymyalgia rheumatica, giant&#xD;
        cell arteritis, rheumatoid arthritis, and vasculitis) in the period between 1st Jan 1998&#xD;
        and 15th March 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years old or over&#xD;
&#xD;
          -  Registered in a participating general practice 1 year or more during the study period&#xD;
&#xD;
          -  Minimum of 1 year prior to study entry meeting CPRD data quality&#xD;
&#xD;
          -  Diagnosed with at least one of the 6 chronic inflammatory diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged under 18 years during the study period&#xD;
&#xD;
          -  Registered in general practices that did not consent to data linkage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Mar Pujades Rodriguez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_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/NCT03760562
org study id: 16_146H
nct id: NCT03760562
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008,
      it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3
      months) glucocorticoids, rising to 3% in women aged over 80 years.

      The aim of the project is to investigate the dose-response estimates of risk of high blood
      pressure associated with oral glucocorticoids.
Hypertension is a chronic condition which affects 1 in 5 of the world adult population. The
      cause of hypertension is unknown in about 95% of patients, whilst 5% are secondary to
      underlying adrenal disorders or other identifiable causes.

      Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008,
      it was estimated that 0.8% of the UK adult population had used long-term (≥ 3 months)
      glucocorticoids, rising to 3% in women aged over 80 years. Glucocorticoids are effective in
      controlling underlying chronic inflammatory disease in majority of cases. However, their
      continuous use can result in a variety of complications, including hypertension.Although it
      is acknowledged that excess cortisol is a leading cause of hypertension, the role of
      exogenous glucocorticoids is less known.

      The aim of the project is to investigate the dose-response estimates of risk of high blood
      pressure associated with oral glucocorticoids.

      This is a retrospective cohort study of people diagnosed with at least one of six chronic
      inflammatory diseases (polymyalgia rheumatica, giant cell arteritis, systemic lupus
      erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease). This study
      will be based on the analysis of existing primary care health records routinely collected,
      linked to hospital and mortality data.
observational model: Cohort
time perspective: Retrospective
measure: Glucocorticoid-related hypertension
time frame: 18 years
description: Number of patients with incident hypertension
intervention type: Drug
intervention name: Glucocorticoids
description: Oral Glucocorticoids.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Mar Pujades Rodriguez
investigator title: Principal Investigator
mesh term: Hypertension
mesh term: Glucocorticoids