<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/NCT02988245</url>
  </required_header>
  <id_info>
    <org_study_id>Geneticure</org_study_id>
    <nct_id>NCT02988245</nct_id>
  </id_info>
  <brief_title>Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension</brief_title>
  <acronym>PGEN for HTN</acronym>
  <official_title>Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geneticure, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fairview Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geneticure, LLC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hypertension is one of the most important preventable contributors to disease and death in&#xD;
      the United States and represents the most common condition seen in the primary care setting.&#xD;
      Approximately 78 million adults living in the U.S. have hypertension with more than 5 million&#xD;
      new diagnoses made each year. Unfortunately, despite a significant impulse in the medical&#xD;
      community to move towards an &quot;individualized medicine&quot; approach to patient centered&#xD;
      treatment, the current clinical treatment strategy is based on a set algorithm which does not&#xD;
      take into account individual patient differences. As a result hypertension is often&#xD;
      sub-optimally treated based on &quot;population averages&quot;, rather than a person's genetic make-up,&#xD;
      with significant burden on our health care system. In fact, 40% of patients who are adherent&#xD;
      to their blood pressure therapy (taking their medicines as prescribed by their clinician) do&#xD;
      not have their blood pressure under control. Previous work has demonstrated significant&#xD;
      functional polymorphisms within the kidney, vessels, and heart that will likely predict a&#xD;
      patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a&#xD;
      retrospective design, has determined that the addition of genetic knowledge to prescribing&#xD;
      can improve therapeutic guidance and decrease the time to blood pressure control&#xD;
      significantly. Despite this, to date, there are no prospective trials to guide blood pressure&#xD;
      therapy using multiple organ systems that are important in the three most common classes of&#xD;
      drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to&#xD;
      determine the efficacy of genetically guided therapeutic options for pharmacologic treatment&#xD;
      of essential hypertension in newly diagnosed patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim:&#xD;
&#xD;
      To determine the efficacy of genetically guided therapeutic options for pharmacologic&#xD;
      treatment of essential hypertension, when compared to conventional standard of care (JNC 8&#xD;
      guideline directed therapy).&#xD;
&#xD;
      Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have&#xD;
      significantly reduced time to optimal blood pressure control compared to conventional&#xD;
      standard of care.&#xD;
&#xD;
      Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have&#xD;
      significantly greater absolute blood pressure reduction compared to conventional standard of&#xD;
      care.&#xD;
&#xD;
      Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to&#xD;
      take fewer classes of blood pressure medicines in order to achieve blood pressure control.&#xD;
&#xD;
      Secondary Aim:&#xD;
&#xD;
      To determine if genetically guided blood pressure therapy reduces number of medication&#xD;
      changes in patients with hypertension.&#xD;
&#xD;
      Hypotheses: Patients randomized to genetically guided blood pressure therapy will have&#xD;
      significantly less medication changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Blood Pressure Control</measure>
    <time_frame>1 year</time_frame>
    <description>Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Blood Pressure</measure>
    <time_frame>1 year</time_frame>
    <description>Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Blood Pressure Medicines</measure>
    <time_frame>1 year</time_frame>
    <description>Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Medication Changes</measure>
    <time_frame>1 year</time_frame>
    <description>Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Genetically-Guided Treatment for HTN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNC-8-Guided Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Geneticure Panel for HTN therapy</intervention_name>
    <description>Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension</description>
    <arm_group_label>Genetically-Guided Treatment for HTN</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNC-8</intervention_name>
    <description>Using JNC-8 guidelines to guide therapy</description>
    <arm_group_label>JNC-8-Guided Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with new diagnosis of hypertension or uncontrolled hypertension and on one&#xD;
             medication&#xD;
&#xD;
          2. Subject is able and willing to provide informed consent&#xD;
&#xD;
          3. Subject is ≥ 30 and ≤ 80 years of age&#xD;
&#xD;
          4. Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has been diagnosed with chronic kidney disease as determined by serum&#xD;
             creatinine levels of &gt;1.3 mg/dl for men and &gt;1.1 for women.&#xD;
&#xD;
          2. Subject has clinically significant cardiac disease as determined by diagnosed coronary&#xD;
             artery disease, diagnosed heart failure, and congenital cardiac disease.&#xD;
&#xD;
          3. Subject has clinically significant vascular disease as determined by diagnosed&#xD;
             peripheral vascular disease and diagnosed pulmonary hypertension.&#xD;
&#xD;
          4. Liver dysfunction is defined using the normal reference range for lower limit of&#xD;
             normal and upper limit of normal used by Fairview labs and as determined by diagnosed&#xD;
             liver disease /cirrhosis as listed in the patient's problem list based on ICD-10.&#xD;
&#xD;
          5. Subject has secondary hypertension.&#xD;
&#xD;
          6. Subject has prior diagnosis of endocrine disorders except uncomplicated type 2&#xD;
             diabetes and well controlled hypothyroidism.&#xD;
&#xD;
          7. Subject is pregnant.&#xD;
&#xD;
          8. Subject is breastfeeding.&#xD;
&#xD;
          9. Subject becomes pregnant during study&#xD;
&#xD;
         10. Subjects lacking the capacity to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Phelps, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fairview Health Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Weihong Tang, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Schulenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fairview Health Services</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric M Snyder, PhD</last_name>
    <phone>18003628109</phone>
    <phone_ext>702</phone_ext>
    <email>eric@geneticure.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas P Olson, PhD</last_name>
    <phone>18003628109</phone>
    <phone_ext>703</phone_ext>
    <email>tom@geneticure.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fairview Health Clinics - Andover</name>
      <address>
        <city>Andover</city>
        <state>Minnesota</state>
        <zip>55304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Clinics - Blaine</name>
      <address>
        <city>Blaine</city>
        <state>Minnesota</state>
        <zip>55449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Clinics - Bloomington, Oxboro</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Brooklyn Park</name>
      <address>
        <city>Brooklyn Park</city>
        <state>Minnesota</state>
        <zip>55443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics- Burnsville</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Columbia Heights</name>
      <address>
        <city>Columbia Heights</city>
        <state>Minnesota</state>
        <zip>55421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Clinics - Edina</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Clinics - Elk River</name>
      <address>
        <city>Elk River</city>
        <state>Minnesota</state>
        <zip>55330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Fridley</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Lino Lakes</name>
      <address>
        <city>Lino Lakes</city>
        <state>Minnesota</state>
        <zip>55014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Hiawatha</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - North Branch</name>
      <address>
        <city>N. Branch</city>
        <state>Minnesota</state>
        <zip>55056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinic - New Brighton</name>
      <address>
        <city>New Brighton</city>
        <state>Minnesota</state>
        <zip>55112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics - Wyoming</name>
      <address>
        <city>Wyoming</city>
        <state>Minnesota</state>
        <zip>55092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Services - Zimmerman</name>
      <address>
        <city>Zimmerman</city>
        <state>Minnesota</state>
        <zip>55398</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.geneticure.com</url>
    <description>Sponsor Site</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT02988245
org study id: Geneticure
nct id: NCT02988245
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Hypertension is one of the most important preventable contributors to disease and death in
      the United States and represents the most common condition seen in the primary care setting.
      Approximately 78 million adults living in the U.S. have hypertension with more than 5 million
      new diagnoses made each year. Unfortunately, despite a significant impulse in the medical
      community to move towards an "individualized medicine" approach to patient centered
      treatment, the current clinical treatment strategy is based on a set algorithm which does not
      take into account individual patient differences. As a result hypertension is often
      sub-optimally treated based on "population averages", rather than a person's genetic make-up,
      with significant burden on our health care system. In fact, 40% of patients who are adherent
      to their blood pressure therapy (taking their medicines as prescribed by their clinician) do
      not have their blood pressure under control. Previous work has demonstrated significant
      functional polymorphisms within the kidney, vessels, and heart that will likely predict a
      patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a
      retrospective design, has determined that the addition of genetic knowledge to prescribing
      can improve therapeutic guidance and decrease the time to blood pressure control
      significantly. Despite this, to date, there are no prospective trials to guide blood pressure
      therapy using multiple organ systems that are important in the three most common classes of
      drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to
      determine the efficacy of genetically guided therapeutic options for pharmacologic treatment
      of essential hypertension in newly diagnosed patients.
Specific Aim:

      To determine the efficacy of genetically guided therapeutic options for pharmacologic
      treatment of essential hypertension, when compared to conventional standard of care (JNC 8
      guideline directed therapy).

      Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have
      significantly reduced time to optimal blood pressure control compared to conventional
      standard of care.

      Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have
      significantly greater absolute blood pressure reduction compared to conventional standard of
      care.

      Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to
      take fewer classes of blood pressure medicines in order to achieve blood pressure control.

      Secondary Aim:

      To determine if genetically guided blood pressure therapy reduces number of medication
      changes in patients with hypertension.

      Hypotheses: Patients randomized to genetically guided blood pressure therapy will have
      significantly less medication changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to Blood Pressure Control
time frame: 1 year
description: Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
measure: Change in Blood Pressure
time frame: 1 year
description: Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing
measure: Number of Blood Pressure Medicines
time frame: 1 year
description: Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
measure: Number of Medication Changes
time frame: 1 year
description: Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
arm group label: Genetically-Guided Treatment for HTN
arm group type: Experimental
description: Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.
arm group label: JNC-8-Guided Treatment
arm group type: Active Comparator
description: Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.
intervention type: Drug
intervention name: Geneticure Panel for HTN therapy
description: Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension
arm group label: Genetically-Guided Treatment for HTN
intervention type: Drug
intervention name: JNC-8
description: Using JNC-8 guidelines to guide therapy
arm group label: JNC-8-Guided Treatment
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pamela Phelps, PharmD
role: Principal Investigator
affiliation: Fairview Health Services
last name: Weihong Tang, MD, PhD
role: Study Director
affiliation: University of Minnesota
last name: Michael Schulenberg, MD
role: Principal Investigator
affiliation: Fairview Health Services
last name: Eric M Snyder, PhD
phone: 18003628109
phone ext: 702
email: eric@geneticure.com
last name: Thomas P Olson, PhD
phone: 18003628109
phone ext: 703
email: tom@geneticure.com
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.geneticure.com
description: Sponsor Site
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No