<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/NCT03001271</url>
  </required_header>
  <id_info>
    <org_study_id>4576/10</org_study_id>
    <nct_id>NCT03001271</nct_id>
  </id_info>
  <brief_title>Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects</brief_title>
  <acronym>Ang-(1-7)</acronym>
  <official_title>Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</source>
  <brief_summary>
    <textblock>
      In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and&#xD;
      demonstrates promising therapeutic potential due to it is generally opposite effects to&#xD;
      Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on&#xD;
      systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and&#xD;
      hypertensive subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of adverse effects after Ang-(1-7) acute administration</measure>
    <time_frame>Along 25 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure Changes after Ang-(1-7) administration</measure>
    <time_frame>Recording along 24 hours</time_frame>
    <description>absence of measure changes in blood pressure or heart rate (increase or decrease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ang-(1-7) effects on Blood Pressure Variability</measure>
    <time_frame>Along 1 hours after Ang-(1-7) acute administration</time_frame>
    <description>Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Changes after Ang-(1-7) administration</measure>
    <time_frame>Recording along 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ang-(1-7) effects on Heart Rate Variability</measure>
    <time_frame>Along 1 hours after Ang-(1-7) acute administration</time_frame>
    <description>Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo and Angiotensin-(1-7) acute infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo and Angiotensin-(1-7) acute infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Angiotensin 1-7</intervention_name>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
    <other_name>Angio-1-7</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Healthy Group Inclusion Criteria:&#xD;
&#xD;
          -  arterial pressure &lt;140/90 mmHg&#xD;
&#xD;
          -  body mass index (BMI) between 18,5 and 29 Kg/m2&#xD;
&#xD;
        Hypertensive Group Inclusion Criteria:&#xD;
&#xD;
          -  anti-hypertensive drug treatment&#xD;
&#xD;
          -  ambulatory blood pressure monitoring (ABMP) &gt;130/85 mmHg&#xD;
&#xD;
          -  body mass index between 18,5 and 29 Kg/m2&#xD;
&#xD;
        Healthy Group Exclusion Criteria:&#xD;
&#xD;
          -  drug treatment&#xD;
&#xD;
          -  recent surgeries&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  previous cardiovascular events&#xD;
&#xD;
          -  high performance athletes&#xD;
&#xD;
          -  dislipidemia&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  renal injury&#xD;
&#xD;
          -  obesity (BMI above 30 kg/m2)&#xD;
&#xD;
          -  alcoholism&#xD;
&#xD;
          -  smoking.&#xD;
&#xD;
        Hypertensive Group Exclusion Criteria:&#xD;
&#xD;
          -  recent surgeries&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  beta-blockers drug treatment&#xD;
&#xD;
          -  previous cardiovascular events&#xD;
&#xD;
          -  high performance athletes&#xD;
&#xD;
          -  dislipidemia&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  renal injury&#xD;
&#xD;
          -  obesity (BMI above 30 kg/m2)&#xD;
&#xD;
          -  alcoholism&#xD;
&#xD;
          -  smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Angiotensin-(1-7)</keyword>
  <keyword>Renin-angiotensin System</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angiotensin I (1-7)</mesh_term>
  </intervention_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/NCT03001271
org study id: 4576/10
nct id: NCT03001271
lead sponsor: 
In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and
      demonstrates promising therapeutic potential due to it is generally opposite effects to
      Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on
      systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and
      hypertensive subjects.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Absence of adverse effects after Ang-(1-7) acute administration
time frame: Along 25 hours
measure: Blood Pressure Changes after Ang-(1-7) administration
time frame: Recording along 24 hours
description: absence of measure changes in blood pressure or heart rate (increase or decrease)
measure: Ang-(1-7) effects on Blood Pressure Variability
time frame: Along 1 hours after Ang-(1-7) acute administration
description: Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
measure: Heart Rate Changes after Ang-(1-7) administration
time frame: Recording along 24 hours
measure: Ang-(1-7) effects on Heart Rate Variability
time frame: Along 1 hours after Ang-(1-7) acute administration
description: Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
arm group label: Healthy Subjects
arm group type: Experimental
description: Placebo and Angiotensin-(1-7) acute infusion
arm group label: Hypertensive Subjects
arm group type: Experimental
description: Placebo and Angiotensin-(1-7) acute infusion
intervention type: Drug
intervention name: Angiotensin 1-7
arm group label: Healthy Subjects
arm group label: Hypertensive Subjects
other name: Angio-1-7
intervention type: Other
intervention name: Placebo
arm group label: Healthy Subjects
arm group label: Hypertensive Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Angiotensin I (1-7)