<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/NCT04470284</url>
  </required_header>
  <id_info>
    <org_study_id>SMART-BP</org_study_id>
    <nct_id>NCT04470284</nct_id>
  </id_info>
  <brief_title>Mobile App for BP Control</brief_title>
  <acronym>SMART-BP</acronym>
  <official_title>Self-Monitoring of and Feed-back Using APP. in TReatment of UnconTroled Blood Pressure (SMART-BP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to&#xD;
      self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based&#xD;
      feed-back algorithm (SMBP-App) group. The App based feed-back algorithm will provide the&#xD;
      patients with instruction in response to the measured BP value, e.g. remind of taking drug,&#xD;
      if high blood pressure is detected.&#xD;
&#xD;
      The primary outcomes are mean systolic BP change and drug compliance at 24-weeks. Secondary&#xD;
      endpoints include mean diastolic BP change at 12-week, mean systolic and diastolic BP change&#xD;
      at 12 and 24 weeks, and drug compliance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, randomized, open-label, multicenter trial to evaluate the&#xD;
      efficacy of SMBP with mobile health application (SMBP-App) compared with SMBP alone.&#xD;
&#xD;
      Patients with hypertension will be randomly assigned to SMBP-App (intervention) and SMBP&#xD;
      along (control) groups. In SMBP group the patients perform home blood pressure measurement&#xD;
      and usual care. In SMBP-App group the patients perform home blood pressure and receive extra&#xD;
      alarm and instructions from the mobile application in response to the obtained blood pressure&#xD;
      value.&#xD;
&#xD;
      The aim of this study is to evaluate whether SMBP-App is superior to SMBP alone in terms of&#xD;
      blood pressure reduction and improved drug compliance in patients with hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean home systolic BP change</measure>
    <time_frame>24 weeks</time_frame>
    <description>mean home systolic BP change from baseline to 24 weeks (Visit 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug adherence</measure>
    <time_frame>24 weeks</time_frame>
    <description>Drug adherence using pill count</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic BP change</measure>
    <time_frame>12 weeks and 24 week</time_frame>
    <description>mean home diastolic BP change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>office BP change</measure>
    <time_frame>12 weeks and 24 week</time_frame>
    <description>office systolic or diastolic BP change from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>SMBP_only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment with SMBP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMBP_mobile_app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SMBP with mobile App based feed-back algorithm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Application</intervention_name>
    <description>SMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance.</description>
    <arm_group_label>SMBP_mobile_app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard SMBP</intervention_name>
    <description>Standard treatment (SMBP-alone)</description>
    <arm_group_label>SMBP_only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients with essential hypertension aged 19 years and above.&#xD;
&#xD;
          2. Patients with essential hypertension who are taking one or more antihypertensive&#xD;
             drugs.&#xD;
&#xD;
          3. Patients whose average systolic and diastolic BP measured 3 times on the reference arm&#xD;
             in the sitting position during Visit 1 is greater than 140 mmHg and 90 mmHg,&#xD;
             respectively.&#xD;
&#xD;
          4. Patients voluntarily consent to participate in this clinical trial&#xD;
&#xD;
          5. Patients who can use a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of secondary hypertension or suspected secondary hypertension,&#xD;
             including coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis,&#xD;
             Cushing's syndrome, pheochromocytoma, and polycystic kidney disease.&#xD;
&#xD;
          2. Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the&#xD;
             screening visit.&#xD;
&#xD;
          3. Patients with ≥ 20 mmHg difference between the highest and the lowest sitting systolic&#xD;
             BP or ≥ 10 mmHg difference between highest and lowest diastolic BP, which is confirmed&#xD;
             by triplicate measurements from the reference arm at screening.&#xD;
&#xD;
          4. Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).&#xD;
&#xD;
          5. Patients who have been continuously taking other medications such as systemic&#xD;
             steroids, thyroid hormones, oral contraceptives (except for menopausal hormone&#xD;
             replacement therapy), psychiatric drugs, non-steroidal anti-inflammatory drugs,&#xD;
             sympathetic drugs, and immune suppressants, which have the potential to affect BP.&#xD;
&#xD;
          6. Patients with symptomatic orthostatic hypotension.&#xD;
&#xD;
          7. Patients with a history of malignant tumors, including leukemia and lymphoma, within&#xD;
             the past 5 years.&#xD;
&#xD;
          8. Patients with a history of autoimmune diseases, such as rheumatoid arthritis and&#xD;
             systemic lupus erythematosus.&#xD;
&#xD;
          9. Patients with clinically significant kidney and liver diseases, such as those on&#xD;
             dialysis, liver cirrhosis, biliary obstruction, and hepatic failure, or those who show&#xD;
             the following findings during the screening visit:&#xD;
&#xD;
               -  Alanine transaminase or aspartate transaminase level is at least 3 times higher&#xD;
                  than the normal upper limit;&#xD;
&#xD;
               -  Total bilirubin level is more than twice the normal upper limit;&#xD;
&#xD;
               -  Blood urea nitrogen level is more than twice the normal upper limit;&#xD;
&#xD;
               -  Alkaline phosphatase level is more than twice the normal upper limit;&#xD;
&#xD;
               -  Creatinine clearance level is less than 10 mL/min.&#xD;
&#xD;
         10. Patients with a history of the following diseases in the past 6 months, which are&#xD;
             determined to be clinically significant by the investigator:&#xD;
&#xD;
               -  Heart failure (NYHA class III and IV), ischemic heart diseases (coronary artery&#xD;
                  diseases, such as angina pectoris and myocardial infarction), peripheral vascular&#xD;
                  diseases, hemodynamically significant valve stenosis, and arrhythmia.&#xD;
&#xD;
               -  Severe cerebrovascular events, including stroke, cerebral infarction, and&#xD;
                  cerebral hemorrhage.&#xD;
&#xD;
         11. Patients with shock.&#xD;
&#xD;
         12. Patients with a history of alcohol or drug abuse.&#xD;
&#xD;
         13. Patients with potential pregnancy or breastfeeding.&#xD;
&#xD;
         14. Patients who will be judged as both legally and psychologically inadequate to&#xD;
             participate in the clinical study by the investigator.&#xD;
&#xD;
         15. Patients who have participated in clinical studies with other investigational drug&#xD;
             products within 4 weeks prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong-Ju Choi, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National Univeristy Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea Univ. Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Guro</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Ju Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_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/NCT04470284
org study id: SMART-BP
nct id: NCT04470284
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to
      self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based
      feed-back algorithm (SMBP-App) group. The App based feed-back algorithm will provide the
      patients with instruction in response to the measured BP value, e.g. remind of taking drug,
      if high blood pressure is detected.

      The primary outcomes are mean systolic BP change and drug compliance at 24-weeks. Secondary
      endpoints include mean diastolic BP change at 12-week, mean systolic and diastolic BP change
      at 12 and 24 weeks, and drug compliance.
This trial is a prospective, randomized, open-label, multicenter trial to evaluate the
      efficacy of SMBP with mobile health application (SMBP-App) compared with SMBP alone.

      Patients with hypertension will be randomly assigned to SMBP-App (intervention) and SMBP
      along (control) groups. In SMBP group the patients perform home blood pressure measurement
      and usual care. In SMBP-App group the patients perform home blood pressure and receive extra
      alarm and instructions from the mobile application in response to the obtained blood pressure
      value.

      The aim of this study is to evaluate whether SMBP-App is superior to SMBP alone in terms of
      blood pressure reduction and improved drug compliance in patients with hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mean home systolic BP change
time frame: 24 weeks
description: mean home systolic BP change from baseline to 24 weeks (Visit 2)
measure: Drug adherence
time frame: 24 weeks
description: Drug adherence using pill count
measure: Diastolic BP change
time frame: 12 weeks and 24 week
description: mean home diastolic BP change from baseline
measure: office BP change
time frame: 12 weeks and 24 week
description: office systolic or diastolic BP change from baseline
arm group label: SMBP_only
arm group type: Active Comparator
description: Standard treatment with SMBP
arm group label: SMBP_mobile_app
arm group type: Experimental
description: SMBP with mobile App based feed-back algorithm
intervention type: Other
intervention name: Mobile Application
description: SMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance.
arm group label: SMBP_mobile_app
intervention type: Other
intervention name: Standard SMBP
description: Standard treatment (SMBP-alone)
arm group label: SMBP_only
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Dong-Ju Choi, MD, PhD
role: Study Chair
affiliation: Seoul National Univeristy Bundang Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Dong-Ju Choi
investigator title: Professor
mesh term: Hypertension