<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/NCT01691781</url>
  </required_header>
  <id_info>
    <org_study_id>2012p0001961</org_study_id>
    <nct_id>NCT01691781</nct_id>
  </id_info>
  <brief_title>The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study</brief_title>
  <acronym>RAAS-PARC</acronym>
  <official_title>The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate whether commonly used blood pressure medications called &quot;ACE&#xD;
      inhibitors&quot; can lower parathyroid hormone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can&#xD;
      lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of&#xD;
      primary hyperparathyroidism.&#xD;
&#xD;
      Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with&#xD;
      increased PTH. The principal investigator, and other investigators, have previously shown&#xD;
      that inhibiting the RAAS may lower PTH. The current study will focus on:&#xD;
&#xD;
        1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH&#xD;
           in normal individuals?&#xD;
&#xD;
        2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary&#xD;
           hyperparathyroidism?&#xD;
&#xD;
      The results of this study may have important implications for cardiovascular and skeletal&#xD;
      health, as both the RAAS and PTH have been implicated as mediators of these conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration</measure>
    <time_frame>1 week</time_frame>
    <description>PTH values 1 week following ACE inhibitor therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Calcium Following 1 Week of ACE Inhibitor Administration</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>lisinopril</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lisinopril - open-label, 2.5-40mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lisinopril</intervention_name>
    <description>Each subject will receive one week of lisinopril and return for repeat for blood measurements.</description>
    <arm_group_label>lisinopril</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects with with no medical problems (n=15) and individuals with primary&#xD;
             hyperparathyroidism (n=30)&#xD;
&#xD;
          -  normal blood pressure or stage 1 hypertension that is either untreated, or adequately&#xD;
             treated with a single anti-hypertensive medication.&#xD;
&#xD;
          -  Age &gt;18 years and &lt;80 years&#xD;
&#xD;
          -  Estimated GFR &gt; 60ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic Kidney Disease or eGFR&lt;60&#xD;
&#xD;
          -  Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug&#xD;
&#xD;
          -  Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a&#xD;
             Hemoglobin A1c &gt;7.5%&#xD;
&#xD;
          -  History of liver failure&#xD;
&#xD;
          -  History of heart failure&#xD;
&#xD;
          -  The use of typical or atypical antipsychotic medications or lithium.&#xD;
&#xD;
          -  Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that&#xD;
             are treated with prescribed doses of NSAIDs or glucocorticoids&#xD;
&#xD;
          -  The use of prescribed doses of potassium supplements.&#xD;
&#xD;
          -  Illness requiring overnight hospitalization in the past 6 months&#xD;
&#xD;
          -  Active tobacco or recreational drug use&#xD;
&#xD;
          -  Pregnancy or current breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anand Vaidya, MD, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital, Harvard Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>June 19, 2017</results_first_submitted>
  <results_first_submitted_qc>July 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2017</results_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Anand Vaidya</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hyperparathyroidism</keyword>
  <keyword>Renin-angiotensin-aldosterone system</keyword>
  <keyword>ACE inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperparathyroidism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lisinopril</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All enrolled participants had to undergo a washout of ACE inhibitors (if applicable) during which time their blood pressure had to remain within safety parameters, and they had to complete a controlled sodium diet.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Primary Hyperparathyroidism</title>
          <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
        <group group_id="P2">
          <title>Normal</title>
          <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Primary Hyperparathyroidism</title>
          <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
        <group group_id="B2">
          <title>Normals</title>
          <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="15.6"/>
                    <measurement group_id="B2" value="39.6" spread="12.7"/>
                    <measurement group_id="B3" value="44.9" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parathyroid Hormone at Baseline</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.5" spread="21.6"/>
                    <measurement group_id="B2" value="33.3" spread="25.4"/>
                    <measurement group_id="B3" value="53.8" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum calcium</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="0.5"/>
                    <measurement group_id="B2" value="9.4" spread="0.4"/>
                    <measurement group_id="B3" value="9.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary Aldosterone Excretion Rate at baseline</title>
          <units>mcg/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.7" spread="18.3"/>
                    <measurement group_id="B2" value="5.7" spread="3.5"/>
                    <measurement group_id="B3" value="8.2" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration</title>
        <description>PTH values 1 week following ACE inhibitor therapy</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Primary Hyperparathyroidism</title>
            <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
          <group group_id="O2">
            <title>Normal</title>
            <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
        </group_list>
        <measure>
          <title>Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration</title>
          <description>PTH values 1 week following ACE inhibitor therapy</description>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9" spread="19.6"/>
                    <measurement group_id="O2" value="32.5" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.049</p_value>
            <p_value_desc>This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <p_value_desc>This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy</title>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Primary Hyperparathyroidism</title>
            <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
          <group group_id="O2">
            <title>Normal</title>
            <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy</title>
          <units>mcg/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="8.9"/>
                    <measurement group_id="O2" value="6.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.22</p_value>
            <p_value_desc>This p-value reflects the comparison of means among the primary hyperparathyroidism group only.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.86</p_value>
            <p_value_desc>This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Calcium Following 1 Week of ACE Inhibitor Administration</title>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Primary Hyperparathyroidism</title>
            <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
          <group group_id="O2">
            <title>Normal</title>
            <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Calcium Following 1 Week of ACE Inhibitor Administration</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="0.4"/>
                    <measurement group_id="O2" value="9.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.48</p_value>
            <p_value_desc>This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <p_value_desc>This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Primary Hyperparathyroidism</title>
          <description>Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
        <group group_id="E2">
          <title>Normal</title>
          <description>Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This a small physiology pilot study that is open-label and non-randomized. The intervention was an ACE inhibitor, an approved therapy. Results have physiologic implications, but treatment implications are not intended.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Anand Vaidya</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>6175258285</phone>
      <email>avaidya1@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01691781
org study id: 2012p0001961
nct id: NCT01691781
lead sponsor: 
has dmc: Yes
This study will evaluate whether commonly used blood pressure medications called "ACE
      inhibitors" can lower parathyroid hormone.
The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can
      lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of
      primary hyperparathyroidism.

      Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with
      increased PTH. The principal investigator, and other investigators, have previously shown
      that inhibiting the RAAS may lower PTH. The current study will focus on:

        1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH
           in normal individuals?

        2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary
           hyperparathyroidism?

      The results of this study may have important implications for cardiovascular and skeletal
      health, as both the RAAS and PTH have been implicated as mediators of these conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
masking description: Open Label
measure: Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
time frame: 1 week
description: PTH values 1 week following ACE inhibitor therapy
measure: Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
time frame: 1 week
measure: Serum Calcium Following 1 Week of ACE Inhibitor Administration
time frame: 1 week
arm group label: lisinopril
arm group type: Experimental
description: Lisinopril - open-label, 2.5-40mg daily
intervention type: Drug
intervention name: Lisinopril
description: Each subject will receive one week of lisinopril and return for repeat for blood measurements.
arm group label: lisinopril
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anand Vaidya, MD, MMSc
role: Principal Investigator
affiliation: Brigham and Women's Hospital, Harvard Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Anand Vaidya
investigator title: Principal Investigator
mesh term: Hyperparathyroidism
mesh term: Lisinopril
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This a small physiology pilot study that is open-label and non-randomized. The intervention was an ACE inhibitor, an approved therapy. Results have physiologic implications, but treatment implications are not intended.
point of contact: 