<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/NCT03035929</url>
  </required_header>
  <id_info>
    <org_study_id>161482</org_study_id>
    <nct_id>NCT03035929</nct_id>
  </id_info>
  <brief_title>Diagnosing Natriuretic Peptide Deficiency</brief_title>
  <official_title>Diagnosing Natriuretic Peptide Deficiency: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this pilot study, the investigators will determine the response of the natriuretic peptide&#xD;
      (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The&#xD;
      goal of the proposed project is to generate preliminary data that will be used to develop&#xD;
      power calculations, inform cutoff ranges, and inform the timing of the NP response for larger&#xD;
      subsequent studies.&#xD;
&#xD;
      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)&#xD;
      responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.&#xD;
&#xD;
      Hypothesis: Determination of the NP responses (the range and time course of changes in NP&#xD;
      levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency&#xD;
      of blood sampling in a definitive prospective study, as well as enable investigators to&#xD;
      perform a sample size calculation for a definitive prospective study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 8, 2017</primary_completion_date>
  <phase>Phase 1</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in NT-proANP From Baseline to 8 Hours</measure>
    <time_frame>baseline and 8 hours</time_frame>
    <description>Change in natriuretic peptide levels after drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in NT-proBNP From Baseline to 8 Hours</measure>
    <time_frame>Baseline and 8 hours</time_frame>
    <description>Change in natriuretic peptide levels after drug administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in NT-proANP</measure>
    <time_frame>baseline, 24 hours, 48 hours and 72 hours</time_frame>
    <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in NT-proBNP</measure>
    <time_frame>at baseline, 24 hours, 48 hours and 72 hours</time_frame>
    <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BNP (B-type Natriuretic Peptide)</measure>
    <time_frame>0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration</time_frame>
    <description>Natriuretic peptide levels after drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ANP (Atrial Natriuretic Peptide)</measure>
    <time_frame>0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration</time_frame>
    <description>Natriuretic peptide levels after drug administration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <condition>Lean</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 Healthy subjects will undergo study procedures at four study visits.&#xD;
All subjects will undergo the same procedures and interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>A single dose of dexamethasone IV 4 mg will be administered.</description>
    <arm_group_label>Healthy</arm_group_label>
    <other_name>Dexamethasone IV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Men and women ages 18-50 years&#xD;
&#xD;
          -  BMI 18.5 to &lt;25 kg/m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant use of systemically-absorbed glucocorticoids currently or for an extended&#xD;
             period of time during the prior 6 months&#xD;
&#xD;
          -  Current use of antihypertensive medications&#xD;
&#xD;
          -  Current use of metformin, or any antidiabetic medications (which could affect glucose&#xD;
             and insulin levels)&#xD;
&#xD;
          -  Current use of medications known to affect dexamethasone metabolism, including&#xD;
             phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates&#xD;
&#xD;
          -  Active, clinically significant infection at time of visit&#xD;
&#xD;
          -  History of adrenal insufficiency or Cushing's syndrome&#xD;
&#xD;
          -  Prior or current cardiovascular disease, renal disease, or liver disease&#xD;
&#xD;
          -  Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose&#xD;
             tolerance&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Bleeding disorder or anemia&#xD;
&#xD;
          -  Elevated Liver Functions Tests &gt; 2 times upper limit of normal&#xD;
&#xD;
          -  Estimated glomerular filtration rate &lt; 60 ml/min&#xD;
&#xD;
          -  HbA1c &gt; 5.7&#xD;
&#xD;
          -  Abnormal sodium or potassium level&#xD;
&#xD;
          -  Positive pregnancy test, women of child-bearing age not practicing birth control,&#xD;
             women who are breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine N Bachmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Endocrinology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>August 20, 2018</results_first_submitted>
  <results_first_submitted_qc>March 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 20, 2019</results_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Katherine N. Bachmann, MD</investigator_full_name>
    <investigator_title>Instructor in Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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>August 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03035929/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1 participant withdrew after consent but before the baseline visit and is not included in the results.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy</title>
          <description>Healthy subjects will be enrolled and each will undergo study procedures at four study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy</title>
          <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" lower_limit="24.5" upper_limit="29.0"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in NT-proANP From Baseline to 8 Hours</title>
        <description>Change in natriuretic peptide levels after drug administration</description>
        <time_frame>baseline and 8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in NT-proANP From Baseline to 8 Hours</title>
          <description>Change in natriuretic peptide levels after drug administration</description>
          <units>nmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in NT-proBNP From Baseline to 8 Hours</title>
        <description>Change in natriuretic peptide levels after drug administration</description>
        <time_frame>Baseline and 8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in NT-proBNP From Baseline to 8 Hours</title>
          <description>Change in natriuretic peptide levels after drug administration</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in NT-proANP</title>
        <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</description>
        <time_frame>baseline, 24 hours, 48 hours and 72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in NT-proANP</title>
          <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</description>
          <units>nmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to 24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread=".22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread=".36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in NT-proBNP</title>
        <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</description>
        <time_frame>at baseline, 24 hours, 48 hours and 72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in NT-proBNP</title>
          <description>Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to 24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.4" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.9" spread="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BNP (B-type Natriuretic Peptide)</title>
        <description>Natriuretic peptide levels after drug administration</description>
        <time_frame>0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration</time_frame>
        <population>Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>BNP (B-type Natriuretic Peptide)</title>
          <description>Natriuretic peptide levels after drug administration</description>
          <population>Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ANP (Atrial Natriuretic Peptide)</title>
        <description>Natriuretic peptide levels after drug administration</description>
        <time_frame>0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration</time_frame>
        <population>Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy</title>
            <description>10 Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>ANP (Atrial Natriuretic Peptide)</title>
          <description>Natriuretic peptide levels after drug administration</description>
          <population>Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy</title>
          <description>Healthy subjects will be enrolled and each will undergo study procedures at three study visits.&#xD;
All subjects will undergo the same procedures and interventions.&#xD;
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered.</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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <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="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Grace Henderson, Study Coordinator</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-936-5356</phone>
      <email>grace.henderson@vumc.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/NCT03035929
org study id: 161482
nct id: NCT03035929
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In this pilot study, the investigators will determine the response of the natriuretic peptide
      (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The
      goal of the proposed project is to generate preliminary data that will be used to develop
      power calculations, inform cutoff ranges, and inform the timing of the NP response for larger
      subsequent studies.

      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)
      responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.

      Hypothesis: Determination of the NP responses (the range and time course of changes in NP
      levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency
      of blood sampling in a definitive prospective study, as well as enable investigators to
      perform a sample size calculation for a definitive prospective study.
see above
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes in NT-proANP From Baseline to 8 Hours
time frame: baseline and 8 hours
description: Change in natriuretic peptide levels after drug administration
measure: Changes in NT-proBNP From Baseline to 8 Hours
time frame: Baseline and 8 hours
description: Change in natriuretic peptide levels after drug administration
measure: Changes in NT-proANP
time frame: baseline, 24 hours, 48 hours and 72 hours
description: Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
measure: Changes in NT-proBNP
time frame: at baseline, 24 hours, 48 hours and 72 hours
description: Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
measure: BNP (B-type Natriuretic Peptide)
time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
description: Natriuretic peptide levels after drug administration
measure: ANP (Atrial Natriuretic Peptide)
time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
description: Natriuretic peptide levels after drug administration
arm group label: Healthy
arm group type: Experimental
description: 10 Healthy subjects will undergo study procedures at four study visits.
All subjects will undergo the same procedures and interventions.
intervention type: Drug
intervention name: Dexamethasone
description: A single dose of dexamethasone IV 4 mg will be administered.
arm group label: Healthy
other name: Dexamethasone IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine N Bachmann, MD
role: Principal Investigator
affiliation: Vanderbilt Endocrinology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Katherine N. Bachmann, MD
investigator title: Instructor in Medicine
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
sharing ipd: Yes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 