<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/NCT03292094</url>
  </required_header>
  <id_info>
    <org_study_id>NWU-00001-12-A1</org_study_id>
    <nct_id>NCT03292094</nct_id>
  </id_info>
  <brief_title>The African-PREDICT Study</brief_title>
  <acronym>PREDICT</acronym>
  <official_title>African Prospective Study for the Early Detection and Identification of Cardiovascular Disease and Hypertension (African-PREDICT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North-West University, South Africa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Foundation of South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mediclinic Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>North-West University, South Africa</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>
      The African-PREDICT study aims to (i) generate new knowledge on the early pathophysiology&#xD;
      accompanying hypertension development in black South Africans; and (ii) to identify early&#xD;
      novel markers or predictors for the development of hypertension and cardiovascular outcome.&#xD;
      By employing also in Africa the latest cutting-edge scientific technologies to measure single&#xD;
      and multiple biomarkers proven to predict hypertension and cardiovascular outcome (such as&#xD;
      multiplex analyses, proteomics and metabolomics), precision medicine may have the potential&#xD;
      to lead to novel strategies in preventing and treating hypertension in Africa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Problem Statement: Recent global analyses have indicated that the highest&#xD;
      blood pressures worldwide are recorded in black populations. The vulnerable cardiovascular&#xD;
      profile of Africans is believed to result from a combination of factors such as rapid&#xD;
      urbanisation, abnormal sodium handling, elevated vascular resistance and arterial stiffness.&#xD;
      The frequent underdiagnoses and ineffective treatment of hypertension in general but&#xD;
      especially in Africans, result in severe complications, such as stroke, heart and kidney&#xD;
      disease. Since diagnosis and treatment are generally unsuccessful in black populations -&#xD;
      especially in low and middle-income countries - prevention is key to curb the rapidly&#xD;
      increasing incidence of death and disability from cardiovascular disease. Cardiovascular risk&#xD;
      prediction in black populations worldwide is inadequate since we do not have a clear&#xD;
      understanding of the complex mechanisms underlying the development of cardiovascular disease.&#xD;
&#xD;
      Main Aim: In the &quot;African PRospective study on the Early Detection and Identification of&#xD;
      Cardiovascular disease and Hypertension&quot; (African-PREDICT) the investigators aim to identify&#xD;
      early markers or predictors for the development of cardiovascular disease in black South&#xD;
      Africans. Only by understanding the early pathophysiology of disease development, and by&#xD;
      identifying markers as potential screening indicators, predictors or targets for&#xD;
      intervention, will the investigators be able to implement successful prevention programes in&#xD;
      Africans at younger ages. The researchers therefore aim to track and monitor change in young,&#xD;
      normotensive black and white individuals (aged 20-30 years) over 10-20 years. To achieve this&#xD;
      the investigators will perform detailed cardiovascular and novel biomarker measurements, as&#xD;
      well as behavioural and biopsychosocial assessments every 4-5 years in order to identify and&#xD;
      understand early changes in cardiovascular function, and specific predictors contributing to&#xD;
      the development of hypertension and target organ damage.&#xD;
&#xD;
      Methodology and Measurements: In 2013 recruitment started, screening and assessment of 1200&#xD;
      normotensive and apparently healthy participants (black N=600 and white N=600) with equal sex&#xD;
      distribution. A wide range of basic and advanced measurements are taken within a Hypertension&#xD;
      Clinic to get a highly detailed profile of the participants at each visit. The following is&#xD;
      obtained: (1) relevant questionnaire data including medical history, lifestyle, social&#xD;
      status, traditional risk factors (age, gender, smoking, alcohol intake) and validated&#xD;
      questionnaires on dietary intake, personality and psychosocial profile; (2) Biological&#xD;
      samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) are taken and&#xD;
      preserved for the short and long-term at -80°C. A wide range of traditional and novel&#xD;
      biomarkers related to hypertension and cardiovascular disease (including amongst others,&#xD;
      lipid profile, glucose, glycated hemoglobin, C-reactive protein, interleukin-6, vitamin D,&#xD;
      full blood count, sodium, potassium, creatinine, renin, aldosterone, angiotensin II, markers&#xD;
      of oxidative stress and nitric oxide bio-availability, cortisol, sex hormones, insulin,&#xD;
      C-peptide, leptin and other adipokines, angiogenic markers, the insulin-like growth&#xD;
      factor-axis, soluble urokinase plasminogen activator receptor, Nt-proBNP, fibulin-1 and novel&#xD;
      markers not yet identified) will be assessed. These samples will also be analysed in an&#xD;
      attempt to identify bio-signatures in terms of the -omics sciences (genomic, metabolomic and&#xD;
      proteomic profiles) as predictors of cardiovascular deterioration; (3) anthropometric&#xD;
      measurements, bio-electrical impedance measurement of body fat and lean mass, and 7-day&#xD;
      physical activitymonitoring; (4) A range of cardiovascular assessments: 24-hour blood&#xD;
      pressure, central arterial pressure, and cardiovascular stress reactivity tests with&#xD;
      continuous finger blood pressure; and (5) Assessments of early target organ damage including&#xD;
      urinary albumin-to-creatinine ratio, carotid intima-media thickness, ECG, echocardiography,&#xD;
      pulse wave velocity, and retinal microvascular calibre and dilation during provocation with a&#xD;
      light flicker test.&#xD;
&#xD;
      Timetable: The project was approved and is endorsed by the National and Provincial Department&#xD;
      of Health, and was approved by the Ethics Committee of the North-West University in 2012&#xD;
      (NWU-00001-12-A1). Screening commenced in November 2012, and research participants started&#xD;
      entering the study from 6 February 2013. Baseline data collection was completed in December&#xD;
      2017. Follow-up assessments commenced in February 2018 and will continue until Dec 2022. The&#xD;
      Health Research Ethics Committee approved continuation of the study for 2020.&#xD;
&#xD;
      Anticipated Outcomes: This project will increase understanding of the complex mechanisms&#xD;
      involved in the aetiology of early cardiovascular changes in relatively young individuals&#xD;
      from African and European ancestry, which will (1) improve ability to identify individuals at&#xD;
      risk before the development of cardiovascular diseases (CVD), and (2) predict the development&#xD;
      of future hypertension and related CVD. Both outcomes will make it possible to develop better&#xD;
      individualised and population-based prevention of CVD contributing to better quality of life.&#xD;
      These results will not only be applicable to Sub-Saharan Africa but are expected to have a&#xD;
      broader impact with regards to white and black populations globally. Results are expected to&#xD;
      have significant scientific impact by means of publications in high-impact journals; and also&#xD;
      to translate directly into novel preventive healthcare policy and practices - translating&#xD;
      into preventive measures regarding the development of CVDs in clinics throughout South&#xD;
      Africa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2013</start_date>
  <completion_date type="Anticipated">December 3, 2027</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Incident Hypertension</measure>
    <time_frame>5 years</time_frame>
    <description>Incident hypertension based on 4 repeated clinic blood pressure measurements, i.e. SBP&gt;=140 mmHg and/or DBP &gt;=90 mmHg.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1202</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Hypertension</condition>
  <condition>Health Risk Behaviors</condition>
  <condition>Arterial Stiffness</condition>
  <condition>Young</condition>
  <condition>Renin Hypertension</condition>
  <arm_group>
    <arm_group_label>Black men</arm_group_label>
    <description>294 young healthy men were included (clinic normotensive, non-HIV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White men</arm_group_label>
    <description>284 young healthy men were included (clinic normotensive, non-HIV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Black women</arm_group_label>
    <description>312 young healthy women were included (clinic normotensive, non-HIV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White women</arm_group_label>
    <description>312 young healthy women were included (clinic normotensive, non-HIV)</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biological samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) were&#xD;
      taken at baseline and each follow-up. Samples are preserved for the short and long-term at&#xD;
      -80°C. We will assess a wide range of traditional and novel biomarkers related to&#xD;
      hypertension and cardiovascular disease. These samples will also be analysed in an attempt to&#xD;
      identify bio-signatures in terms of the -omics sciences (genomic, metabolomic and proteomic&#xD;
      profiles) as predictors of cardiovascular deterioration&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Apparently healthy black and white participants between the ages of 20 and 30 years from&#xD;
        the Potchefstroom area, North West Province, South Africa.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Brachial BP &lt;140 and 90 mmHg&#xD;
&#xD;
          -  HIV uninfected&#xD;
&#xD;
          -  No previous diagnosis or medication for chronic disease&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to move away from the Potchefstroom area in the next 5 years&#xD;
&#xD;
          -  Currently pregnant or breastfeeding&#xD;
&#xD;
          -  Sick on the day of appointment&#xD;
&#xD;
          -  Lack the ability to read or understand English&#xD;
&#xD;
          -  Diagnosed with HIV, Cancer, Tuberculosis, Diabetes, Hypertension, Liver or Kidney&#xD;
             disease, Heart disease&#xD;
&#xD;
          -  Previously had a heart attack or stroke&#xD;
&#xD;
          -  Have suffered a recent trauma or had surgery in the past 3 months&#xD;
&#xD;
          -  Have a phobia for needles&#xD;
&#xD;
          -  Have donated blood in the previous 3 months&#xD;
&#xD;
          -  Taking chronic medication (Anti-inflammatory, for Hypertension of Diabetes, Cortisone,&#xD;
             Anti-Retroviral, Thyroid medication, Cholesterol medication)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alta Schutte, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New South Wales</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carina MC Mels, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North-West University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hypertension Research and Training Clinic</name>
      <address>
        <city>Potchefstroom</city>
        <state>North West</state>
        <zip>2531</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North-West University, South Africa</investigator_affiliation>
    <investigator_full_name>Alta Schutte</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Young</keyword>
  <keyword>Healthy</keyword>
  <keyword>African</keyword>
  <keyword>Longitudinal</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Salt intake</keyword>
  <keyword>Obesity</keyword>
  <keyword>Organ damage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03292094/Prot_SAP_000.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>January 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03292094/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/NCT03292094
org study id: NWU-00001-12-A1
nct id: NCT03292094
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The African-PREDICT study aims to (i) generate new knowledge on the early pathophysiology
      accompanying hypertension development in black South Africans; and (ii) to identify early
      novel markers or predictors for the development of hypertension and cardiovascular outcome.
      By employing also in Africa the latest cutting-edge scientific technologies to measure single
      and multiple biomarkers proven to predict hypertension and cardiovascular outcome (such as
      multiplex analyses, proteomics and metabolomics), precision medicine may have the potential
      to lead to novel strategies in preventing and treating hypertension in Africa.
Background and Problem Statement: Recent global analyses have indicated that the highest
      blood pressures worldwide are recorded in black populations. The vulnerable cardiovascular
      profile of Africans is believed to result from a combination of factors such as rapid
      urbanisation, abnormal sodium handling, elevated vascular resistance and arterial stiffness.
      The frequent underdiagnoses and ineffective treatment of hypertension in general but
      especially in Africans, result in severe complications, such as stroke, heart and kidney
      disease. Since diagnosis and treatment are generally unsuccessful in black populations -
      especially in low and middle-income countries - prevention is key to curb the rapidly
      increasing incidence of death and disability from cardiovascular disease. Cardiovascular risk
      prediction in black populations worldwide is inadequate since we do not have a clear
      understanding of the complex mechanisms underlying the development of cardiovascular disease.

      Main Aim: In the "African PRospective study on the Early Detection and Identification of
      Cardiovascular disease and Hypertension" (African-PREDICT) the investigators aim to identify
      early markers or predictors for the development of cardiovascular disease in black South
      Africans. Only by understanding the early pathophysiology of disease development, and by
      identifying markers as potential screening indicators, predictors or targets for
      intervention, will the investigators be able to implement successful prevention programes in
      Africans at younger ages. The researchers therefore aim to track and monitor change in young,
      normotensive black and white individuals (aged 20-30 years) over 10-20 years. To achieve this
      the investigators will perform detailed cardiovascular and novel biomarker measurements, as
      well as behavioural and biopsychosocial assessments every 4-5 years in order to identify and
      understand early changes in cardiovascular function, and specific predictors contributing to
      the development of hypertension and target organ damage.

      Methodology and Measurements: In 2013 recruitment started, screening and assessment of 1200
      normotensive and apparently healthy participants (black N=600 and white N=600) with equal sex
      distribution. A wide range of basic and advanced measurements are taken within a Hypertension
      Clinic to get a highly detailed profile of the participants at each visit. The following is
      obtained: (1) relevant questionnaire data including medical history, lifestyle, social
      status, traditional risk factors (age, gender, smoking, alcohol intake) and validated
      questionnaires on dietary intake, personality and psychosocial profile; (2) Biological
      samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) are taken and
      preserved for the short and long-term at -80°C. A wide range of traditional and novel
      biomarkers related to hypertension and cardiovascular disease (including amongst others,
      lipid profile, glucose, glycated hemoglobin, C-reactive protein, interleukin-6, vitamin D,
      full blood count, sodium, potassium, creatinine, renin, aldosterone, angiotensin II, markers
      of oxidative stress and nitric oxide bio-availability, cortisol, sex hormones, insulin,
      C-peptide, leptin and other adipokines, angiogenic markers, the insulin-like growth
      factor-axis, soluble urokinase plasminogen activator receptor, Nt-proBNP, fibulin-1 and novel
      markers not yet identified) will be assessed. These samples will also be analysed in an
      attempt to identify bio-signatures in terms of the -omics sciences (genomic, metabolomic and
      proteomic profiles) as predictors of cardiovascular deterioration; (3) anthropometric
      measurements, bio-electrical impedance measurement of body fat and lean mass, and 7-day
      physical activitymonitoring; (4) A range of cardiovascular assessments: 24-hour blood
      pressure, central arterial pressure, and cardiovascular stress reactivity tests with
      continuous finger blood pressure; and (5) Assessments of early target organ damage including
      urinary albumin-to-creatinine ratio, carotid intima-media thickness, ECG, echocardiography,
      pulse wave velocity, and retinal microvascular calibre and dilation during provocation with a
      light flicker test.

      Timetable: The project was approved and is endorsed by the National and Provincial Department
      of Health, and was approved by the Ethics Committee of the North-West University in 2012
      (NWU-00001-12-A1). Screening commenced in November 2012, and research participants started
      entering the study from 6 February 2013. Baseline data collection was completed in December
      2017. Follow-up assessments commenced in February 2018 and will continue until Dec 2022. The
      Health Research Ethics Committee approved continuation of the study for 2020.

      Anticipated Outcomes: This project will increase understanding of the complex mechanisms
      involved in the aetiology of early cardiovascular changes in relatively young individuals
      from African and European ancestry, which will (1) improve ability to identify individuals at
      risk before the development of cardiovascular diseases (CVD), and (2) predict the development
      of future hypertension and related CVD. Both outcomes will make it possible to develop better
      individualised and population-based prevention of CVD contributing to better quality of life.
      These results will not only be applicable to Sub-Saharan Africa but are expected to have a
      broader impact with regards to white and black populations globally. Results are expected to
      have significant scientific impact by means of publications in high-impact journals; and also
      to translate directly into novel preventive healthcare policy and practices - translating
      into preventive measures regarding the development of CVDs in clinics throughout South
      Africa.
observational model: Cohort
time perspective: Prospective
measure: Incident Hypertension
time frame: 5 years
description: Incident hypertension based on 4 repeated clinic blood pressure measurements, i.e. SBP>=140 mmHg and/or DBP >=90 mmHg.
arm group label: Black men
description: 294 young healthy men were included (clinic normotensive, non-HIV)
arm group label: White men
description: 284 young healthy men were included (clinic normotensive, non-HIV)
arm group label: Black women
description: 312 young healthy women were included (clinic normotensive, non-HIV)
arm group label: White women
description: 312 young healthy women were included (clinic normotensive, non-HIV)
Biological samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) were
      taken at baseline and each follow-up. Samples are preserved for the short and long-term at
      -80°C. We will assess a wide range of traditional and novel biomarkers related to
      hypertension and cardiovascular disease. These samples will also be analysed in an attempt to
      identify bio-signatures in terms of the -omics sciences (genomic, metabolomic and proteomic
      profiles) as predictors of cardiovascular deterioration
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alta Schutte, PhD
role: Principal Investigator
affiliation: University of New South Wales
last name: Carina MC Mels, PhD
role: Principal Investigator
affiliation: North-West University
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: North-West University, South Africa
investigator full name: Alta Schutte
investigator title: Professor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
sharing ipd: No
provided document: 
provided document: 