<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/NCT04428827</url>
  </required_header>
  <id_info>
    <org_study_id>PA_Outcome</org_study_id>
    <nct_id>NCT04428827</nct_id>
  </id_info>
  <brief_title>Outcome of Patients With Primary Aldosteronism</brief_title>
  <acronym>PA_Outcome</acronym>
  <official_title>Long-term Outcomes in Patients With Primary Aldosteronism After Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changi General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Majority of patients with hypertension have primary hypertension (without an underlying&#xD;
      cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and&#xD;
      can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone&#xD;
      (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both&#xD;
      glands).&#xD;
&#xD;
      It has been shown that excess aldosterone has other harmful effects in addition to&#xD;
      hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to&#xD;
      increased cardiovascular morbidity and mortality. This is supported by studies showing&#xD;
      reversal of these effects after treatment for PA.&#xD;
&#xD;
      The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients&#xD;
      with PA, compared to patients with essential hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">July 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2022</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>change in systolic blood pressure before and after treatment</measure>
    <time_frame>six months after treatment</time_frame>
    <description>change in systolic blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in diastolic blood pressure before and after treatment</measure>
    <time_frame>six months after treatment</time_frame>
    <description>change in diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in systolic blood pressure before and after treatment</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>change in systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in diastolic blood pressure before and after treatment</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>change in diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular outcome</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>incidence of new cardiovascular events including acute myocardial infarction, revascularisation percutaneously, coronary artery bypass graft, stroke, admission for congestive cardiac failure, atrial fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic kidney disease</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>incidence of worsening chronic kidney disease, decline of glomerular filtration rate by 15ml/min from at least 60m/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Progression</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>rate of decline of glomerular filtration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variables that predict unilateral disease</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Identify variables that are more common in patients with unilateral disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variables that predict blood pressure response</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Identify variables that are more common in patients with positive blood pressure response</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Primary Aldosteronism</condition>
  <condition>Primary Aldosteronism Due to Aldosterone Producing Adenoma</condition>
  <condition>Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)</condition>
  <condition>Adrenalectomy; Status</condition>
  <condition>Mineralocorticoid Excess</condition>
  <condition>Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use</condition>
  <condition>Cardiovascular Morbidity</condition>
  <condition>Chronic Renal Disease</condition>
  <condition>Hypokalemia</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <description>Patients treated with surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medications</arm_group_label>
    <description>Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unilateral adrenalectomy in patients with unilateral disease</intervention_name>
    <description>Unilateral adrenalectomy in patients with unilateral disease</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected primary aldosteronism managed at referral centre for suspected&#xD;
        primary aldosteronism&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected primary aldosteronism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Troy Puar, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changi General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Troy Puar, MRCP</last_name>
    <phone>67888833</phone>
    <email>troy_puar@cgh.com.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Troy Puar</last_name>
      <phone>67888833</phone>
      <email>troy_puar@cgh.com.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
    <mesh_term>Adrenogenital Syndrome</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hypokalemia</mesh_term>
    <mesh_term>Hyperaldosteronism</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing of anonymised pooled data</ipd_description>
  </patient_data>
  <!-- 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/NCT04428827
org study id: PA_Outcome
nct id: NCT04428827
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Majority of patients with hypertension have primary hypertension (without an underlying
      cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and
      can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone
      (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both
      glands).

      It has been shown that excess aldosterone has other harmful effects in addition to
      hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to
      increased cardiovascular morbidity and mortality. This is supported by studies showing
      reversal of these effects after treatment for PA.

      The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients
      with PA, compared to patients with essential hypertension.
observational model: Cohort
time perspective: Retrospective
measure: change in systolic blood pressure before and after treatment
time frame: six months after treatment
description: change in systolic blood pressure
measure: change in diastolic blood pressure before and after treatment
time frame: six months after treatment
description: change in diastolic blood pressure
measure: change in systolic blood pressure before and after treatment
time frame: through study completion, an average of 5 years
description: change in systolic blood pressure
measure: change in diastolic blood pressure before and after treatment
time frame: through study completion, an average of 5 years
description: change in diastolic blood pressure
measure: cardiovascular outcome
time frame: through study completion, an average of 5 years
description: incidence of new cardiovascular events including acute myocardial infarction, revascularisation percutaneously, coronary artery bypass graft, stroke, admission for congestive cardiac failure, atrial fibrillation
measure: chronic kidney disease
time frame: through study completion, an average of 5 years
description: incidence of worsening chronic kidney disease, decline of glomerular filtration rate by 15ml/min from at least 60m/min
measure: Renal Progression
time frame: through study completion, an average of 5 years
description: rate of decline of glomerular filtration rate
measure: variables that predict unilateral disease
time frame: through study completion, an average of 5 years
description: Identify variables that are more common in patients with unilateral disease
measure: variables that predict blood pressure response
time frame: through study completion, an average of 5 years
description: Identify variables that are more common in patients with positive blood pressure response
arm group label: Surgery
description: Patients treated with surgery
arm group label: Medications
description: Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism
intervention type: Procedure
intervention name: Unilateral adrenalectomy in patients with unilateral disease
description: Unilateral adrenalectomy in patients with unilateral disease
arm group label: Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 100 Years
last name: Troy Puar, MRCP
role: Principal Investigator
affiliation: Changi General Hospital
last name: Troy Puar, MRCP
phone: 67888833
email: troy_puar@cgh.com.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Adrenal Hyperplasia, Congenital
mesh term: Adrenogenital Syndrome
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
mesh term: Hypokalemia
mesh term: Hyperaldosteronism
mesh term: Hyperplasia
sharing ipd: Undecided
ipd description: Sharing of anonymised pooled data