<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/NCT02257450</url>
  </required_header>
  <id_info>
    <org_study_id>MyEndo - PA</org_study_id>
    <nct_id>NCT02257450</nct_id>
  </id_info>
  <brief_title>Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study</brief_title>
  <acronym>MyEndo-PA</acronym>
  <official_title>Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Islamic University Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Malaysian Endocrine and Metabolic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University of Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Islamic University Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension (HPT) is a very common disease, expensive to treat with serious morbidity and&#xD;
      mortality. In Malaysia, from the NHMS III conducted in 2006, HPT affects more than 36% of&#xD;
      adults. Essential HPT (HPT with no identifiable cause) accounts for approximately 85% of&#xD;
      cases, whereas 15% have identifiable conditions (secondary cause). The detection of a&#xD;
      secondary cause of HPT is important as the condition is reversible when detected early.&#xD;
      Primary aldosteronism (PA) has been identified as the commonest cause of secondary HPT. At&#xD;
      present, PA has been regarded as the commonest and potentially curable, with a prevalence of&#xD;
      5-13% [1-7]. If this condition is detected early, the chances of cure from hypertension have&#xD;
      been reported up to 80% of cases.&#xD;
&#xD;
      This will translate to a major impact to the Malaysian health-care budget. The costs spent on&#xD;
      life-long BP medications and complications related to HPT can be reduced enormously. PA is a&#xD;
      type of hormonal disorder that leads to high blood pressure (BP). In PA, the adrenal glands&#xD;
      produce too much aldosterone causing sodium retention and potassium excretion. The excess&#xD;
      sodium then increased the blood volume and BP.&#xD;
&#xD;
      Diagnosis and treatment of this condition are of paramount importance because people with&#xD;
      this form of high BP have a higher risk of heart attack, stroke, kidney impairment, metabolic&#xD;
      abnormality and reduce quality of life compared to patients with high BP not due to this&#xD;
      condition. More importantly, the high BP associated with PA may be curable. This research&#xD;
      will be conducted as a multicenter nation-wide study in Malaysia. The research aimed to study&#xD;
      the prevalence of this disease in the investigators Malaysian population, determine the&#xD;
      underlying mechanisms why this disease is associated with higher complication rate through&#xD;
      cardiovascular and inflammatory markers, and identify the genes causing this disease, hence&#xD;
      provide a more rapid diagnostic test and possibility of curing the disease with genetic&#xD;
      therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Aldosterone-Renin Ratio</measure>
    <time_frame>Day 0</time_frame>
    <description>Aldosterone-renin ratio of respondent at the time of sampling</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of Inflammatory Markers</measure>
    <time_frame>Day 0</time_frame>
    <description>Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of cardiovascular markers</measure>
    <time_frame>Day 0</time_frame>
    <description>Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Primary Aldosteronism</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Malaysian adult population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and above&#xD;
&#xD;
          -  Malaysian citizen&#xD;
&#xD;
          -  Consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who refused consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nor Azmi Kamaruddin, FACE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Islamic University Malaysia</investigator_affiliation>
    <investigator_full_name>Dr Mohamnmad Arif Shahar</investigator_full_name>
    <investigator_title>Assist Prof</investigator_title>
  </responsible_party>
  <keyword>Primary Aldosteronism</keyword>
  <keyword>Hyperaldosteronism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperaldosteronism</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/NCT02257450
org study id: MyEndo - PA
nct id: NCT02257450
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult
      population.
Hypertension (HPT) is a very common disease, expensive to treat with serious morbidity and
      mortality. In Malaysia, from the NHMS III conducted in 2006, HPT affects more than 36% of
      adults. Essential HPT (HPT with no identifiable cause) accounts for approximately 85% of
      cases, whereas 15% have identifiable conditions (secondary cause). The detection of a
      secondary cause of HPT is important as the condition is reversible when detected early.
      Primary aldosteronism (PA) has been identified as the commonest cause of secondary HPT. At
      present, PA has been regarded as the commonest and potentially curable, with a prevalence of
      5-13% [1-7]. If this condition is detected early, the chances of cure from hypertension have
      been reported up to 80% of cases.

      This will translate to a major impact to the Malaysian health-care budget. The costs spent on
      life-long BP medications and complications related to HPT can be reduced enormously. PA is a
      type of hormonal disorder that leads to high blood pressure (BP). In PA, the adrenal glands
      produce too much aldosterone causing sodium retention and potassium excretion. The excess
      sodium then increased the blood volume and BP.

      Diagnosis and treatment of this condition are of paramount importance because people with
      this form of high BP have a higher risk of heart attack, stroke, kidney impairment, metabolic
      abnormality and reduce quality of life compared to patients with high BP not due to this
      condition. More importantly, the high BP associated with PA may be curable. This research
      will be conducted as a multicenter nation-wide study in Malaysia. The research aimed to study
      the prevalence of this disease in the investigators Malaysian population, determine the
      underlying mechanisms why this disease is associated with higher complication rate through
      cardiovascular and inflammatory markers, and identify the genes causing this disease, hence
      provide a more rapid diagnostic test and possibility of curing the disease with genetic
      therapy
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Aldosterone-Renin Ratio
time frame: Day 0
description: Aldosterone-renin ratio of respondent at the time of sampling
measure: Level of Inflammatory Markers
time frame: Day 0
description: Level of inflammatory markers (IL-6, hs-CRP) among respondents at the time of sampling
measure: Level of cardiovascular markers
time frame: Day 0
description: Level of cardiovascular markers (BNP, PAI-1) among respondents at the time of sampling
Serum, plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nor Azmi Kamaruddin, FACE
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
responsible party type: Principal Investigator
investigator affiliation: International Islamic University Malaysia
investigator full name: Dr Mohamnmad Arif Shahar
investigator title: Assist Prof
mesh term: Hyperaldosteronism