xml: <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/NCT06012487</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY02827</org_study_id>
      <nct_id>NCT06012487</nct_id>
    </id_info>
    <brief_title>Correlates and Control of Blood Pressure Variability</brief_title>
    <official_title>Correlates and Control of Blood Pressure Variability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cedars-Sinai Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cedars-Sinai Medical Center</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose the research is to prospectively demonstrate agreement between EHR and ambulatory&#xD;
        blood pressure monitor (ABPM) derived blood pressure variability (BPV), as well as the&#xD;
        feasibility of reducing BPV using a data-driven pharmacotherapeutic approach. To this end,&#xD;
        this is a feasibility study that will make use of the Cedars-Sinai Health System including&#xD;
        the Medical Delivery Network and the clinics of all practitioners who use the same EHR.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary research procedures are: assessment of blood pressure variability (BPV) using&#xD;
        ABPM compared to EHR derived values; and to assess feasibility of a data driven&#xD;
        pharmacotherapy intervention to reduce BPV among high BPV patients. As part of an option&#xD;
        sub-study, participants may wear a single lead ECG patch to record skin sympathetic nerve&#xD;
        activity (SKNA), which has been previously correlated with changes in blood pressure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>
      <intervention_model_description>This is a feasibility study of the feasibility of helping physicians select a protocol to reduce BPV in hypertensive patients on antihypertensive therapy. The duration of the study for Aim 2 is 2 visits, the first with a 48 hour ABPM and the second for a repeat 48 hour ABPM following any changes made at the discretion of the treating provider.&#xD;
  The optional sub-study is also a feasibility study, designed to demonstrate the ability to simultaneously capture ABPM and SKNA data.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Blood Pressure Variability</measure>
      <time_frame>48 hours</time_frame>
      <description>Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Blood Pressure Variability</condition>
    <arm_group>
      <arm_group_label>Ambulatory Blood Pressure Monitor (ABPM)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants on antihypertensive pharmacotherapy in the highest decile of BPV will be offered enrollment based on inclusion/exclusion criteria. Patient's will undergo a 48 hour ABPM to determine baseline BPV. Next, each patient's primary care physician will be guided through titrations to antihypertensive medications to a low BPV regimen (Amlodipine and Indapamide, with doses titrated to reach target blood pressure). Following this, patients will undergo repeat 48h ABPM to evaluate change in BPV. All medication decisions will be at the ultimate discretion of the treating physician.&#xD;
  The optional sub-study will test the hypothesize that ABPM and SKNA data can be simultaneously captured and that BPV will be positively correlated with SKNA. Participants who enroll in the optional sub-study will be fitted with a single patch ECG which will capture high-fidelity ECG tracings from which SKNA can be determine in post-test analysis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Low BPV Regimen</intervention_name>
      <description>Each the patients' physician will invite patients to complete a 48-hour ABPM, then undergo cross-titration from their current antihypertensive regimen to a low BPV regimen, consisting of Amlodipine and Indapamide. Study staff will suggest to the treating physician to initially start patients on Amlodipine 5mg daily, with uptitration to 10mg daily to a goal systolic blood pressure (SBP)&lt;130 mmHg. Indapamide will be suggested to be added at 1.25mg daily and increased to 2.5mg daily, as needed to meet target SBP. Other antihypertensive medications will be suggested to be discontinued as the SBP target is reached. Patients not meeting target SBP on maximally tolerated Amlodipine and Indapamide will be suggested to have a long acting angiotensin-converting enzyme (ACE)/ angiotensin receptor blocker (ARB) added to their therapy. Patients will complete another 48-hour ABPM after 1 week at target SBP on the low-BPV regimen.</description>
      <arm_group_label>Ambulatory Blood Pressure Monitor (ABPM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals 18 years old or older are included.&#xD;
  &#xD;
            -  Patients followed continuously at Cedars-Sinai for at least 5 years, defined as at&#xD;
               least 1 outpatient visit with a Cedars-Sinai physician at which a blood pressure was&#xD;
               measured each of the last 2 calendar years&#xD;
  &#xD;
            -  Patients with a PCP in the Cedars-Sinai Medical Group or faculty practice&#xD;
  &#xD;
            -  Patients on antihypertensive therapy other than a DPH-CCB or thiazide-like diuretic&#xD;
  &#xD;
            -  Patients in the highest decile of BPV based on extracted BP data from the EHR&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any records flagged &quot;break the glass&quot; or &quot;research opt out.&quot;&#xD;
  &#xD;
            -  Pregnant or breastfeeding patients (due to guideline recommendations for specific&#xD;
               medications for the treatment of hypertension during pregnancy and breastfeeding).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joseph Ebinger</last_name>
      <phone>3104230925</phone>
      <email>cda-research@cshs.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Joseph Ebinger</investigator_full_name>
      <investigator_title>Assistant Professor of Cardiology</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012487
  org study id: STUDY02827
  nct id: NCT06012487
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose the research is to prospectively demonstrate agreement between EHR and ambulatory
        blood pressure monitor (ABPM) derived blood pressure variability (BPV), as well as the
        feasibility of reducing BPV using a data-driven pharmacotherapeutic approach. To this end,
        this is a feasibility study that will make use of the Cedars-Sinai Health System including
        the Medical Delivery Network and the clinics of all practitioners who use the same EHR.
  The primary research procedures are: assessment of blood pressure variability (BPV) using
        ABPM compared to EHR derived values; and to assess feasibility of a data driven
        pharmacotherapy intervention to reduce BPV among high BPV patients. As part of an option
        sub-study, participants may wear a single lead ECG patch to record skin sympathetic nerve
        activity (SKNA), which has been previously correlated with changes in blood pressure.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is a feasibility study of the feasibility of helping physicians select a protocol to reduce BPV in hypertensive patients on antihypertensive therapy. The duration of the study for Aim 2 is 2 visits, the first with a 48 hour ABPM and the second for a repeat 48 hour ABPM following any changes made at the discretion of the treating provider.
  The optional sub-study is also a feasibility study, designed to demonstrate the ability to simultaneously capture ABPM and SKNA data.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Change in Blood Pressure Variability
  time frame: 48 hours
  description: Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM
  arm group label: Ambulatory Blood Pressure Monitor (ABPM)
  arm group type: Other
  description: Participants on antihypertensive pharmacotherapy in the highest decile of BPV will be offered enrollment based on inclusion/exclusion criteria. Patient's will undergo a 48 hour ABPM to determine baseline BPV. Next, each patient's primary care physician will be guided through titrations to antihypertensive medications to a low BPV regimen (Amlodipine and Indapamide, with doses titrated to reach target blood pressure). Following this, patients will undergo repeat 48h ABPM to evaluate change in BPV. All medication decisions will be at the ultimate discretion of the treating physician.
  The optional sub-study will test the hypothesize that ABPM and SKNA data can be simultaneously captured and that BPV will be positively correlated with SKNA. Participants who enroll in the optional sub-study will be fitted with a single patch ECG which will capture high-fidelity ECG tracings from which SKNA can be determine in post-test analysis.
  intervention type: Drug
  intervention name: Low BPV Regimen
  description: Each the patients' physician will invite patients to complete a 48-hour ABPM, then undergo cross-titration from their current antihypertensive regimen to a low BPV regimen, consisting of Amlodipine and Indapamide. Study staff will suggest to the treating physician to initially start patients on Amlodipine 5mg daily, with uptitration to 10mg daily to a goal systolic blood pressure (SBP)<130 mmHg. Indapamide will be suggested to be added at 1.25mg daily and increased to 2.5mg daily, as needed to meet target SBP. Other antihypertensive medications will be suggested to be discontinued as the SBP target is reached. Patients not meeting target SBP on maximally tolerated Amlodipine and Indapamide will be suggested to have a long acting angiotensin-converting enzyme (ACE)/ angiotensin receptor blocker (ARB) added to their therapy. Patients will complete another 48-hour ABPM after 1 week at target SBP on the low-BPV regimen.
  arm group label: Ambulatory Blood Pressure Monitor (ABPM)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joseph Ebinger
  phone: 3104230925
  email: cda-research@cshs.org
  responsible party type: Principal Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Joseph Ebinger
  investigator title: Assistant Professor of Cardiology
  sharing ipd: No