<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/NCT02243904</url>
  </required_header>
  <id_info>
    <org_study_id>SPHERL</org_study_id>
    <nct_id>NCT02243904</nct_id>
  </id_info>
  <brief_title>Study for Promotion of Health in Recycling Lead</brief_title>
  <acronym>SPHERL</acronym>
  <official_title>Study for Promotion of Health in Recycling Lead</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up&#xD;
      study of lead workers with exposure levels varying between and within individuals. SPHERL&#xD;
      addresses to what extent between-subject differences or within-subject changes in lead&#xD;
      exposure may have a measurable impact on blood pressure, the cardiovascular system, renal&#xD;
      function, the autonomic nervous system, peripheral nervous conduction velocity, and&#xD;
      neurocognitive function.&#xD;
&#xD;
      At the beginning of December 2015, 70 participants were included in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
        -  Whether low-level lead exposure impacts on blood pressure, regulation of the&#xD;
           cardiovascular system, glomerular or tubular renal function, sympathetic nervous&#xD;
           modulation, peripheral nervous conduction velocity, and neurocognitive function remains&#xD;
           uncertain.&#xD;
&#xD;
      Study Population&#xD;
&#xD;
        -  SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be&#xD;
           examined at baseline (2014-2015) and followed up at annual intervals for 2 years&#xD;
           (2016-2017).&#xD;
&#xD;
      Methods&#xD;
&#xD;
        -  Volunteers eligible for the study are (i) new and existing hires without previous&#xD;
           occupational lead exposure who will be performing tasks with or without occupational&#xD;
           lead exposure and (ii) existing hires with occupational lead exposure who will be&#xD;
           transitioning to job tasks without occupational lead exposure within the next 2 years.&#xD;
&#xD;
        -  Blood lead concentration will be the main biomarker of exposure.&#xD;
&#xD;
        -  The main outcome variables are (i) blood pressure measured conventionally and by&#xD;
           ambulatory monitoring, and analyzed as continuous or categorical variable, both&#xD;
           cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal&#xD;
           function, (iii) heart rate variability analyzed in the frequency domain as measure of&#xD;
           autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v)&#xD;
           neurocognitive performance, (vi) and quality of life [the EuroQOL five dimensions&#xD;
           (EQ-5D) questionnaire].&#xD;
&#xD;
      Expected Outcomes&#xD;
&#xD;
        -  Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered&#xD;
           to demonstrate over 2 years an acceleration in the age-related rise of systolic blood&#xD;
           pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination&#xD;
           (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models&#xD;
           relating changes in blood pressure to three other covariables. The longitudinal design&#xD;
           of our study complies with the temporality principle of the Bradford-Hill criteria for&#xD;
           assessing possible causality between outcomes and exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</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>Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annual change in central hemodynamics</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in the central hemodynamics, including aortic blood pressure, the central systolic augmentation index, and aortic pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in heart function</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in ECG-derived indexes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in renal function</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in glomerular and tubular renal function measured on a continuous scale and the incidence of renal dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in autonomic nervous function</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in alterations in the autonomic nervous cardiovascular modulation, as assessed by heart rate variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in peripheral nervous conduction velocity</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in nerve conduction velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in neurocognitive performance</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in neurocognitive testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual change in quality of life</measure>
    <time_frame>Baseline, 1 year and 2 years</time_frame>
    <description>Annual changes in self-assessed quality of life</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">270</enrollment>
  <condition>Occupational Exposure</condition>
  <arm_group>
    <arm_group_label>Lead exposure</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited among the work force employed at lead recycling plants in&#xD;
        North America.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men are eligible.&#xD;
&#xD;
          -  New hires without previous occupational lead exposure who will be performing tasks&#xD;
             with lead exposure or current employees without previous occupational lead exposure&#xD;
             moving to tasks with exposure.&#xD;
&#xD;
          -  Informed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Any serious health condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan A Staessen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Hara A, Gu YM, Petit T, Liu YP, Jacobs L, Zhang ZY, Yang WY, Jin Y, Thijs L, Wei FF, Nawrot TS, Staessen JA. Study for Promotion of Health in Recycling Lead - Rationale and design. Blood Press. 2015 Jun;24(3):147-57. doi: 10.3109/08037051.2014.996409. Epub 2015 Jan 26.</citation>
    <PMID>25620211</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Jan A. Staessen</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Autonomic nervous function</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Cardiovascular regulation</keyword>
  <keyword>Lead</keyword>
  <keyword>Occupational exposure</keyword>
  <keyword>Renal function</keyword>
  <!-- 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/NCT02243904
org study id: SPHERL
nct id: NCT02243904
lead sponsor: 
has dmc: No
Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up
      study of lead workers with exposure levels varying between and within individuals. SPHERL
      addresses to what extent between-subject differences or within-subject changes in lead
      exposure may have a measurable impact on blood pressure, the cardiovascular system, renal
      function, the autonomic nervous system, peripheral nervous conduction velocity, and
      neurocognitive function.

      At the beginning of December 2015, 70 participants were included in the study.
Background

        -  Whether low-level lead exposure impacts on blood pressure, regulation of the
           cardiovascular system, glomerular or tubular renal function, sympathetic nervous
           modulation, peripheral nervous conduction velocity, and neurocognitive function remains
           uncertain.

      Study Population

        -  SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be
           examined at baseline (2014-2015) and followed up at annual intervals for 2 years
           (2016-2017).

      Methods

        -  Volunteers eligible for the study are (i) new and existing hires without previous
           occupational lead exposure who will be performing tasks with or without occupational
           lead exposure and (ii) existing hires with occupational lead exposure who will be
           transitioning to job tasks without occupational lead exposure within the next 2 years.

        -  Blood lead concentration will be the main biomarker of exposure.

        -  The main outcome variables are (i) blood pressure measured conventionally and by
           ambulatory monitoring, and analyzed as continuous or categorical variable, both
           cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal
           function, (iii) heart rate variability analyzed in the frequency domain as measure of
           autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v)
           neurocognitive performance, (vi) and quality of life [the EuroQOL five dimensions
           (EQ-5D) questionnaire].

      Expected Outcomes

        -  Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered
           to demonstrate over 2 years an acceleration in the age-related rise of systolic blood
           pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination
           (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models
           relating changes in blood pressure to three other covariables. The longitudinal design
           of our study complies with the temporality principle of the Bradford-Hill criteria for
           assessing possible causality between outcomes and exposure.
observational model: Cohort
time perspective: Prospective
measure: Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring
time frame: Baseline, 1 year and 2 years
measure: Annual change in central hemodynamics
time frame: Baseline, 1 year and 2 years
description: Annual changes in the central hemodynamics, including aortic blood pressure, the central systolic augmentation index, and aortic pulse wave velocity
measure: Annual change in heart function
time frame: Baseline, 1 year and 2 years
description: Annual changes in ECG-derived indexes
measure: Annual change in renal function
time frame: Baseline, 1 year and 2 years
description: Annual changes in glomerular and tubular renal function measured on a continuous scale and the incidence of renal dysfunction
measure: Annual change in autonomic nervous function
time frame: Baseline, 1 year and 2 years
description: Annual changes in alterations in the autonomic nervous cardiovascular modulation, as assessed by heart rate variability
measure: Annual change in peripheral nervous conduction velocity
time frame: Baseline, 1 year and 2 years
description: Annual changes in nerve conduction velocity
measure: Annual change in neurocognitive performance
time frame: Baseline, 1 year and 2 years
description: Annual changes in neurocognitive testing
measure: Annual change in quality of life
time frame: Baseline, 1 year and 2 years
description: Annual changes in self-assessed quality of life
arm group label: Lead exposure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jan A Staessen, MD, PhD
role: Principal Investigator
affiliation: University of Leuven
facility: 
country: Belgium
citation: Hara A, Gu YM, Petit T, Liu YP, Jacobs L, Zhang ZY, Yang WY, Jin Y, Thijs L, Wei FF, Nawrot TS, Staessen JA. Study for Promotion of Health in Recycling Lead - Rationale and design. Blood Press. 2015 Jun;24(3):147-57. doi: 10.3109/08037051.2014.996409. Epub 2015 Jan 26.
PMID: 25620211
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Jan A. Staessen
investigator title: Professor of Medicine