<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/NCT03826745</url>
  </required_header>
  <id_info>
    <org_study_id>PMC-60-009</org_study_id>
    <nct_id>NCT03826745</nct_id>
  </id_info>
  <brief_title>The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease</brief_title>
  <official_title>The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trinity Hypertension &amp; Metabolic Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trinity Hypertension &amp; Metabolic Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study is to determine the presence of the human sequence on Ang-(1-12) in the plasma of&#xD;
      normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.&#xD;
&#xD;
      To measure concentrations of Ang-(1-12) in either serum or spot urine collections from male&#xD;
      and female normal, hypertensive and/or resistant hypertensive subjects.&#xD;
&#xD;
      To assess whether chymase activity can be detected in human serum and urine using the&#xD;
      radiolabeled amino acid sequence of 1251-Ang-(1-12)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Ang-(1-12) in Human Plasma/Urine</measure>
    <time_frame>one day</time_frame>
    <description>Determine the presence of the human sequence of Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.</description>
  </primary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Cardiovascular Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plasma/Urine</intervention_name>
    <description>Plasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human Plasma and Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        25 normotensive subjects (40-50% females) aged 40 years and above, 25 untreated or treated&#xD;
        essential hypertensive subject (40-50%) females) age 40 years and above, and 25 subjects&#xD;
        with diagnosis of resistant hypertension (blood pressure not controlled on 3 or more drugs)&#xD;
        (40-50% female) aged 40 years and above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cable of reading, comprehending the consent process and providing written informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
          -  Male or female equal/over 40 years of age.&#xD;
&#xD;
          -  Currently being treated with 3 medications and are not at goal seated, Blood pressure&#xD;
             of Systolic blood pressure less 140 mmHg and/or Diastolic blood pressure less 90 mmHg&#xD;
             (Diabetic patients goal seated blood pressure- Systolic blood pressure less 130 and/or&#xD;
             Diastolic blood pressure less 80) OR&#xD;
&#xD;
          -  Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood&#xD;
             pressure of equal/over 90 mmHg and equal/less 115 mmHg and/or Systolic blood pressure&#xD;
             equal/over 140 mmHg and equal/less 180 mmHg OR&#xD;
&#xD;
          -  Normotensive patients defined as a blood pressure less 140/90 mmHg&#xD;
&#xD;
          -  Women may be enrolled if all three of the following criteria are met:&#xD;
&#xD;
          -  Have a negative urine pregnancy test at screening, for females of childbearing&#xD;
             potential&#xD;
&#xD;
          -  Are not breastfeeding&#xD;
&#xD;
          -  Do not plan t become pregnant during the study&#xD;
&#xD;
          -  And if one of the following three criteria is met:&#xD;
&#xD;
          -  Have had a hysterectomy or tubal ligation at least 6 months prior to signing the&#xD;
             informed consent form&#xD;
&#xD;
          -  Have been postmenopausal for at least 1 year&#xD;
&#xD;
          -  Are of childbearing potential and will practice one of the following methods of birth&#xD;
             control throughout the study: oral, patch, injectable, or implantable hormone&#xD;
             contraception, intrauterine device, diaphragm plus spermicide or female condom plus&#xD;
             spermicide. Abstinence, partner's vasectomy are not acceptable methods of&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe hypertension (mean seated cuff Diastolic blood pressure over 115&#xD;
             mmHg or mean seated Systolic blood pressure over 180 mmHg) or any form of secondary&#xD;
             hypertension at time of screening.&#xD;
&#xD;
          -  Patients within the past 6 months with a history of hypertensive encephalopathy,&#xD;
             stroke or transient ischemic attack.&#xD;
&#xD;
          -  Patients within the last 6 months with a history of myocardial infarction,&#xD;
             percutaneous transluminal coronary revascularization, coronary bypass graft, valvular&#xD;
             surgery or unstable angina.&#xD;
&#xD;
          -  Patients with a history of heart block greater than First Degree Sino atrial Block,&#xD;
             Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial&#xD;
             Flutter, Congestive Heart Failure, or other manifestations of clinically significant&#xD;
             cardiac valvular disease.&#xD;
&#xD;
          -  Patients with hemodynamically significant cardiac valvular disease.&#xD;
&#xD;
          -  Patients with evidence of significant chronic renal impairment as indicated by a serum&#xD;
             creatinine of over 2.5mmg/dl at Visit 1.&#xD;
&#xD;
          -  Patients with evidence of liver disease as indicated by Aspartate transaminase (Serum&#xD;
             glutamic oxaloacetic) or Alanine aminotransferase (Serum glutamic pyruvic&#xD;
             transaminase) over 2.5 times or total bilirubin over 1.5 times, the upper limit of the&#xD;
             laboratory normal range at Visit 1.&#xD;
&#xD;
          -  Patients who demonstrate other laboratory test values deviating from the normal range&#xD;
             which are considered to be clinically significant by the investigator.&#xD;
&#xD;
          -  Patients with insulin and non-insulin dependent diabetes mellitus not controlled on&#xD;
             diet, insulin or oral hypoglycemic as defined by a Hemoglobin A1c over 10.5 % at Visit&#xD;
             1.&#xD;
&#xD;
          -  Severe psychological or emotional condition which may interfere with participation in&#xD;
             the study.&#xD;
&#xD;
          -  History of or current use of illicit drugs or alcohol abuse.&#xD;
&#xD;
          -  Participation in a clinical trial and taking any investigational drug within 30 days&#xD;
             prior to enrolling into the study (Visit 1).&#xD;
&#xD;
          -  A physical condition that would limit accurate Blood pressure measurement.&#xD;
&#xD;
          -  Any other medical condition which, in the Investigator's opinion, may render the&#xD;
             patient unable to complete the study or which would interfere with optimal&#xD;
             participation in the study or produce significant risk to the patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry A Punzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Punzi Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Henry A Punzi, MD</last_name>
    <phone>972-478-7700</phone>
    <email>punzimedcenter@aol.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kathy Cassidy, RN</last_name>
    <phone>972-478-7700</phone>
    <email>clinicalresearch@punzimedicalcenter.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Punzi Medical Center</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henry A Punzi, MD</last_name>
      <phone>972-478-7700</phone>
      <email>punzimedcenter@aol.com</email>
    </contact>
    <contact_backup>
      <last_name>Kathy Cassidy, RN</last_name>
      <phone>972-478-7700</phone>
      <email>clinicalresearch@punzimedicalcenter.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Trinity Hypertension &amp; Metabolic Research Institute</investigator_affiliation>
    <investigator_full_name>Henry Anthony Punzi</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03826745
org study id: PMC-60-009
nct id: NCT03826745
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease
Study is to determine the presence of the human sequence on Ang-(1-12) in the plasma of
      normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.

      To measure concentrations of Ang-(1-12) in either serum or spot urine collections from male
      and female normal, hypertensive and/or resistant hypertensive subjects.

      To assess whether chymase activity can be detected in human serum and urine using the
      radiolabeled amino acid sequence of 1251-Ang-(1-12)
observational model: Cohort
time perspective: Prospective
measure: Presence of Ang-(1-12) in Human Plasma/Urine
time frame: one day
description: Determine the presence of the human sequence of Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.
intervention type: Other
intervention name: Plasma/Urine
description: Plasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects.
Human Plasma and Urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Henry A Punzi, MD
role: Principal Investigator
affiliation: Punzi Medical Center
last name: Henry A Punzi, MD
phone: 972-478-7700
email: punzimedcenter@aol.com
last name: Kathy Cassidy, RN
phone: 972-478-7700
email: clinicalresearch@punzimedicalcenter.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Trinity Hypertension & Metabolic Research Institute
investigator full name: Henry Anthony Punzi
investigator title: Medical Director
mesh term: Cardiovascular Diseases
sharing ipd: No