<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/NCT03305562</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00046001</org_study_id>
    <nct_id>NCT03305562</nct_id>
  </id_info>
  <brief_title>Pediatric Hypertension Registry (PHREG)</brief_title>
  <acronym>PHREG</acronym>
  <official_title>Pediatric Hypertension Registry (PHREG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and&#xD;
      renal disease. But even during childhood, hypertension is associated with significant&#xD;
      morbidity, including cognitive impairment and organ damage. However, the cause of pediatric&#xD;
      hypertension, the response to treatment, and the mechanisms behind organ damage are&#xD;
      incompletely understood. Due to these limitations, there are no first-line medications, and&#xD;
      treatment is often inadequate. An improved comprehension of the course of pediatric&#xD;
      hypertension could enhance clinical care. The goal of this proposal is to create a registry&#xD;
      of patients with hypertension to better enable research into this important disease. This&#xD;
      patient registry will enhance the investigators ability to quickly collect and analyze data&#xD;
      for research studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will include all subjects evaluated at the Brenner Children's Hospital&#xD;
      Pediatric Nephrology clinic since January 1st, 2013 with a diagnosis of high blood pressure&#xD;
      confirmed with three separate blood pressure measurements &gt;=90th percentile for age, sex, and&#xD;
      height, or &gt;120/80 mmHg. The investigators will exclude patients whose initial evaluation&#xD;
      occurred on or after their 18th birthday.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was a pilot study and the investigators received funding to initiate the main study&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">June 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>10 years</time_frame>
    <description>Auscultated blood pressure measurements in clinic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular hypertrophy</measure>
    <time_frame>10 years</time_frame>
    <description>Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albuminuria</measure>
    <time_frame>10 years</time_frame>
    <description>Urinary albumin-to-creatinine (&gt;30 mg/g)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ambulatory blood pressure</measure>
    <time_frame>10 years</time_frame>
    <description>Ambulatory blood pressure monitoring data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>10 years</time_frame>
    <description>Glomerular filtration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric acid</measure>
    <time_frame>10 years</time_frame>
    <description>Serum uric acid</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">179</enrollment>
  <condition>Hypertension</condition>
  <condition>Pediatric Disorder</condition>
  <arm_group>
    <arm_group_label>Retrospective cohort</arm_group_label>
    <description>The cohort of patients seen prior to the implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected retrospectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective cohort</arm_group_label>
    <description>The cohort of patients seen initially seen after implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected prospectively.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects that are patients in the Brenner Children's Hospital Pediatric Nephrology Clinic&#xD;
        or Emory University Pediatric Nephrology with a confirmed diagnosis of high blood pressure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients at one of the following : Wake Forest Baptist Health Brenner Children's Hospital&#xD;
        Pediatric Nephrology clinic Emory University Pediatric Nephrology&#xD;
&#xD;
          -  Diagnosis of hypertension confirmed with three separate blood pressure measurements&#xD;
&#xD;
          -  Diagnosis after January 2013&#xD;
&#xD;
          -  &gt;90th percentile for age, sex, height, or &gt;120/80.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients whose initial evaluation occurred on or after their 18th birthday.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew M South, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Pediatric Nephrology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Din-Dzietham R, Liu Y, Bielo MV, Shamsa F. High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007 Sep 25;116(13):1488-96. doi: 10.1161/CIRCULATIONAHA.106.683243. Epub 2007 Sep 10.</citation>
    <PMID>17846287</PMID>
  </reference>
  <reference>
    <citation>Richey PA, Disessa TG, Somes GW, Alpert BS, Jones DP. Left ventricular geometry in children and adolescents with primary hypertension. Am J Hypertens. 2010 Jan;23(1):24-9. doi: 10.1038/ajh.2009.164. Epub 2009 Oct 22.</citation>
    <PMID>19851297</PMID>
  </reference>
  <reference>
    <citation>King JT Jr, DiLuna ML, Cicchetti DV, Tsevat J, Roberts MS. Cognitive functioning in patients with cerebral aneurysms measured with the mini mental state examination and the telephone interview for cognitive status. Neurosurgery. 2006 Oct;59(4):803-10; discussion 810-1. doi: 10.1227/01.NEU.0000232666.67779.41.</citation>
    <PMID>17038944</PMID>
  </reference>
  <reference>
    <citation>Washburn LK, Nixon PA, Russell GB, Snively BM, O'Shea TM. Preterm Birth Is Associated with Higher Uric Acid Levels in Adolescents. J Pediatr. 2015 Jul;167(1):76-80. doi: 10.1016/j.jpeds.2015.03.043. Epub 2015 Apr 11.</citation>
    <PMID>25868431</PMID>
  </reference>
  <reference>
    <citation>Feig DI, Soletsky B, Johnson RJ. Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension: a randomized trial. JAMA. 2008 Aug 27;300(8):924-32. doi: 10.1001/jama.300.8.924.</citation>
    <PMID>18728266</PMID>
  </reference>
  <reference>
    <citation>Mazzali M, Hughes J, Kim YG, Jefferson JA, Kang DH, Gordon KL, Lan HY, Kivlighn S, Johnson RJ. Elevated uric acid increases blood pressure in the rat by a novel crystal-independent mechanism. Hypertension. 2001 Nov;38(5):1101-6. doi: 10.1161/hy1101.092839.</citation>
    <PMID>11711505</PMID>
  </reference>
  <reference>
    <citation>Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11. 2002 May;(246):1-190.</citation>
    <PMID>12043359</PMID>
  </reference>
  <reference>
    <citation>Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4.</citation>
    <PMID>3588043</PMID>
  </reference>
  <reference>
    <citation>Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.</citation>
    <PMID>24591341</PMID>
  </reference>
  <reference>
    <citation>Khoury PR, Mitsnefes M, Daniels SR, Kimball TR. Age-specific reference intervals for indexed left ventricular mass in children. J Am Soc Echocardiogr. 2009 Jun;22(6):709-14. doi: 10.1016/j.echo.2009.03.003. Epub 2009 May 7.</citation>
    <PMID>19423289</PMID>
  </reference>
  <reference>
    <citation>Rademacher ER, Sinaiko AR. Albuminuria in children. Curr Opin Nephrol Hypertens. 2009 May;18(3):246-51. doi: 10.1097/MNH.0b013e3283294b98.</citation>
    <PMID>19276802</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03305562/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03305562/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03305562
org study id: IRB00046001
nct id: NCT03305562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and
      renal disease. But even during childhood, hypertension is associated with significant
      morbidity, including cognitive impairment and organ damage. However, the cause of pediatric
      hypertension, the response to treatment, and the mechanisms behind organ damage are
      incompletely understood. Due to these limitations, there are no first-line medications, and
      treatment is often inadequate. An improved comprehension of the course of pediatric
      hypertension could enhance clinical care. The goal of this proposal is to create a registry
      of patients with hypertension to better enable research into this important disease. This
      patient registry will enhance the investigators ability to quickly collect and analyze data
      for research studies.
The investigators will include all subjects evaluated at the Brenner Children's Hospital
      Pediatric Nephrology clinic since January 1st, 2013 with a diagnosis of high blood pressure
      confirmed with three separate blood pressure measurements >=90th percentile for age, sex, and
      height, or >120/80 mmHg. The investigators will exclude patients whose initial evaluation
      occurred on or after their 18th birthday.
observational model: Cohort
time perspective: Other
measure: Blood pressure
time frame: 10 years
description: Auscultated blood pressure measurements in clinic
measure: Left ventricular hypertrophy
time frame: 10 years
description: Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms
measure: Albuminuria
time frame: 10 years
description: Urinary albumin-to-creatinine (>30 mg/g)
measure: Ambulatory blood pressure
time frame: 10 years
description: Ambulatory blood pressure monitoring data
measure: Renal function
time frame: 10 years
description: Glomerular filtration rate
measure: Uric acid
time frame: 10 years
description: Serum uric acid
arm group label: Retrospective cohort
description: The cohort of patients seen prior to the implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected retrospectively.
arm group label: Prospective cohort
description: The cohort of patients seen initially seen after implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected prospectively.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Andrew M South, MD MS
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
facility: 
country: United States
citation: Din-Dzietham R, Liu Y, Bielo MV, Shamsa F. High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007 Sep 25;116(13):1488-96. doi: 10.1161/CIRCULATIONAHA.106.683243. Epub 2007 Sep 10.
PMID: 17846287
citation: Richey PA, Disessa TG, Somes GW, Alpert BS, Jones DP. Left ventricular geometry in children and adolescents with primary hypertension. Am J Hypertens. 2010 Jan;23(1):24-9. doi: 10.1038/ajh.2009.164. Epub 2009 Oct 22.
PMID: 19851297
citation: King JT Jr, DiLuna ML, Cicchetti DV, Tsevat J, Roberts MS. Cognitive functioning in patients with cerebral aneurysms measured with the mini mental state examination and the telephone interview for cognitive status. Neurosurgery. 2006 Oct;59(4):803-10; discussion 810-1. doi: 10.1227/01.NEU.0000232666.67779.41.
PMID: 17038944
citation: Washburn LK, Nixon PA, Russell GB, Snively BM, O'Shea TM. Preterm Birth Is Associated with Higher Uric Acid Levels in Adolescents. J Pediatr. 2015 Jul;167(1):76-80. doi: 10.1016/j.jpeds.2015.03.043. Epub 2015 Apr 11.
PMID: 25868431
citation: Feig DI, Soletsky B, Johnson RJ. Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension: a randomized trial. JAMA. 2008 Aug 27;300(8):924-32. doi: 10.1001/jama.300.8.924.
PMID: 18728266
citation: Mazzali M, Hughes J, Kim YG, Jefferson JA, Kang DH, Gordon KL, Lan HY, Kivlighn S, Johnson RJ. Elevated uric acid increases blood pressure in the rat by a novel crystal-independent mechanism. Hypertension. 2001 Nov;38(5):1101-6. doi: 10.1161/hy1101.092839.
PMID: 11711505
citation: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11. 2002 May;(246):1-190.
PMID: 12043359
citation: Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4.
PMID: 3588043
citation: Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
PMID: 24591341
citation: Khoury PR, Mitsnefes M, Daniels SR, Kimball TR. Age-specific reference intervals for indexed left ventricular mass in children. J Am Soc Echocardiogr. 2009 Jun;22(6):709-14. doi: 10.1016/j.echo.2009.03.003. Epub 2009 May 7.
PMID: 19423289
citation: Rademacher ER, Sinaiko AR. Albuminuria in children. Curr Opin Nephrol Hypertens. 2009 May;18(3):246-51. doi: 10.1097/MNH.0b013e3283294b98.
PMID: 19276802
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
provided document: 
provided document: 