<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/NCT03284099</url>
  </required_header>
  <id_info>
    <org_study_id>2017.182-T</org_study_id>
    <nct_id>NCT03284099</nct_id>
  </id_info>
  <brief_title>Bedtime ACEIs/ARBs Versus Morning ACEIs/ARBs for Reverting Non-dipping Hypertension</brief_title>
  <official_title>Is Bedtime Administration of ACEIs and ARBs More Effective for Reverting Non-dipper Status Than Morning Administration for Non-dipping Hypertension in Hong Kong Primary Care? A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <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>
      Background: Non-dipping (ND), defined as a &lt;10% decrease in blood pressure (BP) during sleep,&#xD;
      is an independent significant predictor of cardiovascular outcome in hypertensive patients. A&#xD;
      few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and&#xD;
      angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at&#xD;
      night. Chinese data are scarce and there are no prospective studies on cardiovascular&#xD;
      outcomes in Chinese patients.&#xD;
&#xD;
      Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at&#xD;
      normalizing ND than morning administration. As a pilot project, the feasibility of recruiting&#xD;
      hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and&#xD;
      conducting a clinical trial will be evaluated such that future larger randomized trials can&#xD;
      be planned to determine treatments for ND.&#xD;
&#xD;
      Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs&#xD;
      or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning&#xD;
      or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine&#xD;
      post-treatment changes in BP and ND status.&#xD;
&#xD;
      Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks;&#xD;
      secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii)&#xD;
      feasibility of this pilot study will be assessed by recruitment and dropout rates during the&#xD;
      study period.&#xD;
&#xD;
      Potential: This pilot study will provide the basis for a future larger randomized controlled&#xD;
      study to further examine the treatment for ND in primary care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No funding obtained. The ABPM machines are being used for another project&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of non-dipping in each group as measured by ambulatory BP machines(ABPM)</measure>
    <time_frame>6 weeks</time_frame>
    <description>the ABPM - An ApneABP (Meditech, Hungary) will be used in the study. non-dipping is defined as lack of more than 10% drop in SBP during sleep when compared to awake BP. The sleep duration and time are defined by actigraphy (Actigraph, model GT9X-BT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean awake and asleep SBP/DBP of 48-hour duration as assessed by ABPM</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>feasibility of the intervention as assessed by dropout rate</measure>
    <time_frame>1 year (assessed after the whole study)</time_frame>
    <description>The trial is deemed feasible and a larger similar study can be conducted if: (i) ≤30% of ND patients drop out from the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Hypertension</condition>
  <condition>Non-Dipping</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACEIs or ARBs will be switch to be taken before bedtime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACEIs or ARBs will be taken in the morning as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACEi, ARB</intervention_name>
    <description>To take the ACEis or ARBs before bedtime instead of in the morning</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are taking an ACEI or an ARB&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Chinese and&#xD;
&#xD;
          -  Received a diagnosis of primary HT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe HT as defined by a clinic systolic BP ≥180 mmHg and/or diastolic BP ≥ 110 mmHg&#xD;
&#xD;
          -  allergic reaction or intolerance to the current ACEI or ARB&#xD;
&#xD;
          -  unable to provide consent&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  night-time worker&#xD;
&#xD;
          -  occupational drivers since patients will be asked not to move during BP measurements,&#xD;
             which may induce potential danger in driving&#xD;
&#xD;
          -  taking anti-coagulants to avoid causing bruises when using ABPM&#xD;
&#xD;
          -  known atrial fibrillation since ABPM use has not been validated in this group&#xD;
&#xD;
          -  known hyperkalemia&#xD;
&#xD;
          -  ABPM discovered hypotension (mean SBP &lt; 100 and/or mean DBP &lt; 60) because these&#xD;
             patients may need to stop their medications&#xD;
&#xD;
          -  Reported sleep time of &lt;4 hours per night (at least seven readings are recommended&#xD;
             during sleep for an ABPM recording to be valid, and a sleeping time &lt; 4 hours is&#xD;
             unlikely to generate valid results).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lek Yuen Clinic</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Lee Kam Pui</investigator_full_name>
    <investigator_title>Assistant 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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>to decide after end of trial</ipd_description>
  </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/NCT03284099
org study id: 2017.182-T
nct id: NCT03284099
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Non-dipping (ND), defined as a <10% decrease in blood pressure (BP) during sleep,
      is an independent significant predictor of cardiovascular outcome in hypertensive patients. A
      few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and
      angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at
      night. Chinese data are scarce and there are no prospective studies on cardiovascular
      outcomes in Chinese patients.

      Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at
      normalizing ND than morning administration. As a pilot project, the feasibility of recruiting
      hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and
      conducting a clinical trial will be evaluated such that future larger randomized trials can
      be planned to determine treatments for ND.

      Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs
      or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning
      or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine
      post-treatment changes in BP and ND status.

      Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks;
      secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii)
      feasibility of this pilot study will be assessed by recruitment and dropout rates during the
      study period.

      Potential: This pilot study will provide the basis for a future larger randomized controlled
      study to further examine the treatment for ND in primary care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: proportion of non-dipping in each group as measured by ambulatory BP machines(ABPM)
time frame: 6 weeks
description: the ABPM - An ApneABP (Meditech, Hungary) will be used in the study. non-dipping is defined as lack of more than 10% drop in SBP during sleep when compared to awake BP. The sleep duration and time are defined by actigraphy (Actigraph, model GT9X-BT)
measure: mean awake and asleep SBP/DBP of 48-hour duration as assessed by ABPM
time frame: 6 weeks
measure: feasibility of the intervention as assessed by dropout rate
time frame: 1 year (assessed after the whole study)
description: The trial is deemed feasible and a larger similar study can be conducted if: (i) ≤30% of ND patients drop out from the study
arm group label: intervention
arm group type: Experimental
description: ACEIs or ARBs will be switch to be taken before bedtime
arm group label: control
arm group type: Active Comparator
description: ACEIs or ARBs will be taken in the morning as usual
intervention type: Drug
intervention name: ACEi, ARB
description: To take the ACEis or ARBs before bedtime instead of in the morning
arm group label: control
arm group label: intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Lee Kam Pui
investigator title: Assistant Professor
mesh term: Hypertension
sharing ipd: Undecided
ipd description: to decide after end of trial