<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/NCT03001427</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00055703_1</org_study_id>
    <nct_id>NCT03001427</nct_id>
  </id_info>
  <brief_title>Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension</brief_title>
  <official_title>Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining&#xD;
      the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop&#xD;
      Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control&#xD;
      BP in individuals with RH. In the parent trial, participants with RH will be randomized to&#xD;
      either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise&#xD;
      and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control&#xD;
      condition.&#xD;
&#xD;
      The current protocol will collect additional assessments of neurocognition (executive&#xD;
      function, processing speed, and memory), endothelial function (brachial artery flow-mediated&#xD;
      dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in&#xD;
      120 participants at baseline, following completion of the 4-month intervention, and again&#xD;
      after one year, in order to examine neurocognitive improvements and their potential&#xD;
      mediators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</primary_completion_date>
  <phase>N/A</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Executive Function composite</measure>
    <time_frame>Baseline to immediate post-treatment (4 months)</time_frame>
    <description>Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Processing Speed composite</measure>
    <time_frame>Baseline to immediate post-treatment (4 months)</time_frame>
    <description>Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&amp;7 Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Memory composite</measure>
    <time_frame>Baseline to immediate post-treatment (4 months)</time_frame>
    <description>CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brachial Artery Flow-Mediated Dilation</measure>
    <time_frame>Baseline to immediate post-treatment (4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prefrontal Cortex Tissue Oxygenation Index</measure>
    <time_frame>Baseline to immediate post-treatment (4 months)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Executive Function composite</measure>
    <time_frame>Baseline to follow-up (1 year)</time_frame>
    <description>Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Processing Speed composite</measure>
    <time_frame>Baseline to follow-up (1 year)</time_frame>
    <description>Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&amp;7 Test</description>
  </other_outcome>
  <other_outcome>
    <measure>Memory composite</measure>
    <time_frame>Baseline to follow-up (1 year)</time_frame>
    <description>CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Treatment-Resistant Hypertension</condition>
  <arm_group>
    <arm_group_label>Structured center-based lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard education and physician advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured center-based lifestyle intervention</intervention_name>
    <arm_group_label>Structured center-based lifestyle intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard education and physician advice</intervention_name>
    <arm_group_label>Standard education and physician advice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented resistant hypertension (RH). In the absence of a specific RH diagnosis,&#xD;
             individuals being treated for two or more weeks with 3 antihypertensive medications of&#xD;
             different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or&#xD;
             DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more&#xD;
             antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP&#xD;
             ≥ 80 mm Hg will also be eligible.&#xD;
&#xD;
          -  Adherent to prescribed medications&#xD;
&#xD;
          -  Overweight (BMI ≥ 25 kg/m2)&#xD;
&#xD;
          -  Sedentary&#xD;
&#xD;
          -  Willing to be randomized to one of the 2 treatment groups and able to fully&#xD;
             participate in intervention&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary HTN, non-adherence to anti-HTN medications&#xD;
&#xD;
          -  Severe CKD (eGFR &lt;40 ml/min/1.73m2)&#xD;
&#xD;
          -  Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at &lt;85%&#xD;
             heart rate reserve on treadmill testing)&#xD;
&#xD;
          -  Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe&#xD;
             valvular heart disease&#xD;
&#xD;
          -  Severe asthma or chronic obstructive lung disease&#xD;
&#xD;
          -  Diabetes requiring insulin&#xD;
&#xD;
          -  Musculoskeletal or neurologic problems that would preclude participation in aerobic&#xD;
             exercise training&#xD;
&#xD;
          -  Major psychiatric disorder, a history of drug abuse, alcohol consumption &gt;14&#xD;
             drinks/week&#xD;
&#xD;
          -  Life-limiting comorbid medical condition such as cancer&#xD;
&#xD;
          -  Prior gastric bypass surgery&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Cognitively impaired&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Blumenthal JA, Sherwood A, Smith PJ, Mabe S, Watkins L, Lin PH, Craighead LW, Babyak M, Tyson C, Young K, Ashworth M, Kraus W, Liao L, Hinderliter A. Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial. Am Heart J. 2015 Nov;170(5):986-994.e5. doi: 10.1016/j.ahj.2015.08.006. Epub 2015 Aug 14.</citation>
    <PMID>26542509</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 20, 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>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</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/NCT03001427
org study id: Pro00055703_1
nct id: NCT03001427
lead sponsor: 
has dmc: Yes
This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining
      the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop
      Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control
      BP in individuals with RH. In the parent trial, participants with RH will be randomized to
      either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise
      and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control
      condition.

      The current protocol will collect additional assessments of neurocognition (executive
      function, processing speed, and memory), endothelial function (brachial artery flow-mediated
      dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in
      120 participants at baseline, following completion of the 4-month intervention, and again
      after one year, in order to examine neurocognitive improvements and their potential
      mediators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Executive Function composite
time frame: Baseline to immediate post-treatment (4 months)
description: Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
measure: Processing Speed composite
time frame: Baseline to immediate post-treatment (4 months)
description: Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test
measure: Memory composite
time frame: Baseline to immediate post-treatment (4 months)
description: CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
measure: Brachial Artery Flow-Mediated Dilation
time frame: Baseline to immediate post-treatment (4 months)
measure: Prefrontal Cortex Tissue Oxygenation Index
time frame: Baseline to immediate post-treatment (4 months)
measure: Executive Function composite
time frame: Baseline to follow-up (1 year)
description: Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
measure: Processing Speed composite
time frame: Baseline to follow-up (1 year)
description: Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test
measure: Memory composite
time frame: Baseline to follow-up (1 year)
description: CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
arm group label: Structured center-based lifestyle intervention
arm group type: Experimental
description: The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.
arm group label: Standard education and physician advice
arm group type: Experimental
description: The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations.
intervention type: Behavioral
intervention name: Structured center-based lifestyle intervention
arm group label: Structured center-based lifestyle intervention
intervention type: Behavioral
intervention name: Standard education and physician advice
arm group label: Standard education and physician advice
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Blumenthal JA, Sherwood A, Smith PJ, Mabe S, Watkins L, Lin PH, Craighead LW, Babyak M, Tyson C, Young K, Ashworth M, Kraus W, Liao L, Hinderliter A. Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial. Am Heart J. 2015 Nov;170(5):986-994.e5. doi: 10.1016/j.ahj.2015.08.006. Epub 2015 Aug 14.
PMID: 26542509
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No