<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/NCT04484350</url>
  </required_header>
  <id_info>
    <org_study_id>DETECT-v1.0</org_study_id>
    <nct_id>NCT04484350</nct_id>
  </id_info>
  <brief_title>Blood Pressure Management in Stroke Following Endovascular Treatment</brief_title>
  <acronym>DETECT</acronym>
  <official_title>Blood Pressure Management in Stroke Following Endovascular Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the&#xD;
      hypothesis that intensive blood pressure control immediately after successful endovascular&#xD;
      stroke thrombectomy can improve patient outcomes. Patients with stroke who have ongoing high&#xD;
      blood pressure after successful clot retrieval will be included. Participants will be&#xD;
      randomly placed (like flipping a coin) in one of two groups. There will be a 50% chance of&#xD;
      each patient being placed to either group. The first group will be allowed to have a higher&#xD;
      blood pressure range that is consistent with current recommendations. The second group will&#xD;
      be given medications to bring their blood pressure down into a normal range. These blood&#xD;
      pressure targets will be maintained for 48 hours. We will collect patient brain images and&#xD;
      levels of stroke disability up to 90 days after their clot retrieval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current guidelines from the American Heart Association/ American Stroke Association (AHA/&#xD;
      ASA) propose thresholds of systolic blood pressure (BP) less than 180 mm Hg and diastolic BP&#xD;
      less than 105 mm Hg during and for the first 24 hours following endovascular treatment (EVT),&#xD;
      which have been arbitrarily inherited from previous intravenous thrombolysis guidelines.&#xD;
      Although there is plethora of evidence from observational cohort studies suggesting that&#xD;
      increased BP following EVT is associated with higher likelihood of both intracranial&#xD;
      hemorrhage and unfavorable clinical outcomes, the potential for residual confounding in these&#xD;
      observational datasets limits their interpretation. The blooD prEssure management in sTroke&#xD;
      following EndovasCular Treatment (DETECT) trial is a single-center, pragmatic, pilot,&#xD;
      prospective open label, blinded end point, randomized controlled trial testing the hypothesis&#xD;
      that intensive BP management following successful EVT is feasible. The primary objective of&#xD;
      DETECT is to determine the feasibility of a RCT assessing the efficacy and safety of&#xD;
      intensive BP lowering compared to standard of care in rates of hemorrhagic transformation and&#xD;
      functional outcome following successful EVT in acute ischemic stroke patients with large&#xD;
      vessel occlusion. We will include adult patients with acute ischemic stroke achieving&#xD;
      successful reperfusion (TICI more or equal to 2b) of a proximal large vessel occlusion in the&#xD;
      anterior circulation after EVT. Eligible patients will be randomized 1:1 within 60 minutes&#xD;
      from the end of the EVT procedure to either intensive (systolic BP target &lt;140 mmHg) or&#xD;
      standard BP management (systolic BP target &lt;180 mmHg) for the first 48 hours after&#xD;
      randomization. Patients with presence of concomitant ipsilateral or contralateral&#xD;
      extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT, and/or&#xD;
      patients having any medical condition where randomization to either standard or intensive BP&#xD;
      lowering would not be acceptable at the discretion of the treating physician will be excluded&#xD;
      from participating. The trial will be embedded within an established national EVT registry&#xD;
      that focuses on improving quality of management of patients receiving EVT for ischemic&#xD;
      stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Anticipated">May 23, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 23, 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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean enrollment rate.</measure>
    <time_frame>through study completion, an average of 18 months</time_frame>
    <description>The predefined target is to achieve a mean enrollment rate of 2 patients per month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment allocation change.</measure>
    <time_frame>48 hours from treatment initiation</time_frame>
    <description>The predefined target is that at least 80% of the participants remain within their assigned treatment group, and not changing treatment allocation for any reason.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any intracranial hemorrhage.</measure>
    <time_frame>24±12 hours from treatment initiation</time_frame>
    <description>As identified in the follow-up computed tomography scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute difference in flow velocity measurements in transcranial Doppler.</measure>
    <time_frame>0-18 hours from treatment initiation</time_frame>
    <description>Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute difference in the NIH Stroke Scale change at day 1.</measure>
    <time_frame>24±12 hours from treatment initiation</time_frame>
    <description>NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute difference in the NIH Stroke Scale change at day 2.</measure>
    <time_frame>48±12 hours from treatment initiation</time_frame>
    <description>NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Absolute difference in mean systolic blood pressure values.</measure>
    <time_frame>48 hours from treatment initiation</time_frame>
    <description>Difference in mean systolic blood pressure values between the two arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with symptomatic intracranial hemorrhage.</measure>
    <time_frame>24±12 hours from treatment initiation</time_frame>
    <description>According to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST), National Institute of Neurological Disorders and Stroke (NINDS) and European-Australian Cooperative Acute Stroke Study 2 (ECASS 2) definitions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of deaths during hospitalization.</measure>
    <time_frame>Day 7 from treatment initiation or hospital discharge</time_frame>
    <description>All-cause in-hospital mortality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of deaths during follow-up.</measure>
    <time_frame>Day 90±10 from treatment initiation</time_frame>
    <description>All-cause mortality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with neurological deterioration.</measure>
    <time_frame>24 hours from treatment initiation</time_frame>
    <description>Defined as ≥4 points decline in the National Institute of Health Stroke Scale (NIHSS) from randomization or death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional outcome during hospitalization.</measure>
    <time_frame>Day 7 from treatment initiation or hospital discharge</time_frame>
    <description>Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional outcome during follow-up.</measure>
    <time_frame>Day 90±10 from treatment initiation</time_frame>
    <description>Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with favorable functional outcomes during hospitalization.</measure>
    <time_frame>Day 7 from treatment initiation or hospital discharge</time_frame>
    <description>Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with favorable functional outcomes during follow-up</measure>
    <time_frame>Day 90±10 from treatment initiation</time_frame>
    <description>Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Absolute difference in the decline of the Alberta stroke program early CT scores.</measure>
    <time_frame>24±12 hours from treatment initiation</time_frame>
    <description>The Alberta Stroke Program Early CT Score (ASPECTS) is a 10-point (range 0-10) quantitative topographic imaging scale with higher scores indicating more favorable imaging profiles. Differences will be assessed between the baseline and repeat computed tomography scan.</description>
  </other_outcome>
  <other_outcome>
    <measure>Absolute difference in final infarct volumes.</measure>
    <time_frame>Day 7 from treatment initiation</time_frame>
    <description>As assessed in the magnetic resonance imaging (MRI) scan, when available.</description>
  </other_outcome>
  <other_outcome>
    <measure>Absolute difference in hospital stay.</measure>
    <time_frame>Day 7 from treatment initiation or hospital discharge</time_frame>
    <description>Duration of hospital length of stay in days.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>Vessels; Occlusion</condition>
  <condition>Blood Pressure</condition>
  <condition>Endovascular Thrombectomy</condition>
  <condition>Mechanical Thrombectomy</condition>
  <arm_group>
    <arm_group_label>Intensive Blood Pressure management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the intensive blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 140 mmHg for the first 48 hours after enrollment into the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Blood Pressure management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to the standard blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 180 mmHg for the first 48 hours after enrollment into the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Labetalol</intervention_name>
    <description>10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)</description>
    <arm_group_label>Intensive Blood Pressure management</arm_group_label>
    <arm_group_label>Standard Blood Pressure management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydralazine</intervention_name>
    <description>10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)</description>
    <arm_group_label>Intensive Blood Pressure management</arm_group_label>
    <arm_group_label>Standard Blood Pressure management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enalapril</intervention_name>
    <description>1.25 - 2.5 mg IV bolus and then q6h PRN.</description>
    <arm_group_label>Intensive Blood Pressure management</arm_group_label>
    <arm_group_label>Standard Blood Pressure management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal or more than 18 years.&#xD;
&#xD;
          -  Eligible for endovascular treatment (EVT) within 24 hours from symptom onset according&#xD;
             to current clinical practice.&#xD;
&#xD;
          -  Presence of a proximal large vessel occlusion in the anterior circulation, defined as&#xD;
             occlusion of the intracranial segment of the internal carotid artery and/or occlusion&#xD;
             of the M1 segment or proximal M2 segment of the middle cerebral artery.&#xD;
&#xD;
          -  Successful recanalization after the end of the EVT procedure, defined as modified&#xD;
             thrombolysis in cerebral ischemia (mTICI) score equal or more than 2b.&#xD;
&#xD;
          -  Sustained elevated systolic BP level after recanalization, defined as 2 consecutive&#xD;
             systolic BP readings ≥ 150 mmHg (or ≥ 140 mmHg if the participant has a known history&#xD;
             of hypertension) taken more than 5 minutes apart.&#xD;
&#xD;
          -  Ability of the patient or legal representative to provide informed consent.&#xD;
&#xD;
          -  Randomization within 60 minutes from the end of the EVT procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or&#xD;
             remaining stenosis ≥80% after the end of the EVT.&#xD;
&#xD;
          -  Symptomatic intracranial hemorrhage after the end of EVT procedure.&#xD;
&#xD;
          -  Any medical condition where randomization to either standard or intensive BP lowering&#xD;
             would not be acceptable at the discretion of the investigators and/or the treating&#xD;
             physician.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Enrollment in another acute stroke therapeutic trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aristeidis H Katsanos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton General Hospital, Hamilton Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endovascular stroke treatment</keyword>
  <keyword>successful recanalization</keyword>
  <keyword>transcranial Doppler Ultrasound</keyword>
  <keyword>intracranial hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enalapril</mesh_term>
    <mesh_term>Labetalol</mesh_term>
    <mesh_term>Hydralazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04484350
org study id: DETECT-v1.0
nct id: NCT04484350
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the
      hypothesis that intensive blood pressure control immediately after successful endovascular
      stroke thrombectomy can improve patient outcomes. Patients with stroke who have ongoing high
      blood pressure after successful clot retrieval will be included. Participants will be
      randomly placed (like flipping a coin) in one of two groups. There will be a 50% chance of
      each patient being placed to either group. The first group will be allowed to have a higher
      blood pressure range that is consistent with current recommendations. The second group will
      be given medications to bring their blood pressure down into a normal range. These blood
      pressure targets will be maintained for 48 hours. We will collect patient brain images and
      levels of stroke disability up to 90 days after their clot retrieval.
Current guidelines from the American Heart Association/ American Stroke Association (AHA/
      ASA) propose thresholds of systolic blood pressure (BP) less than 180 mm Hg and diastolic BP
      less than 105 mm Hg during and for the first 24 hours following endovascular treatment (EVT),
      which have been arbitrarily inherited from previous intravenous thrombolysis guidelines.
      Although there is plethora of evidence from observational cohort studies suggesting that
      increased BP following EVT is associated with higher likelihood of both intracranial
      hemorrhage and unfavorable clinical outcomes, the potential for residual confounding in these
      observational datasets limits their interpretation. The blooD prEssure management in sTroke
      following EndovasCular Treatment (DETECT) trial is a single-center, pragmatic, pilot,
      prospective open label, blinded end point, randomized controlled trial testing the hypothesis
      that intensive BP management following successful EVT is feasible. The primary objective of
      DETECT is to determine the feasibility of a RCT assessing the efficacy and safety of
      intensive BP lowering compared to standard of care in rates of hemorrhagic transformation and
      functional outcome following successful EVT in acute ischemic stroke patients with large
      vessel occlusion. We will include adult patients with acute ischemic stroke achieving
      successful reperfusion (TICI more or equal to 2b) of a proximal large vessel occlusion in the
      anterior circulation after EVT. Eligible patients will be randomized 1:1 within 60 minutes
      from the end of the EVT procedure to either intensive (systolic BP target <140 mmHg) or
      standard BP management (systolic BP target <180 mmHg) for the first 48 hours after
      randomization. Patients with presence of concomitant ipsilateral or contralateral
      extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT, and/or
      patients having any medical condition where randomization to either standard or intensive BP
      lowering would not be acceptable at the discretion of the treating physician will be excluded
      from participating. The trial will be embedded within an established national EVT registry
      that focuses on improving quality of management of patients receiving EVT for ischemic
      stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean enrollment rate.
time frame: through study completion, an average of 18 months
description: The predefined target is to achieve a mean enrollment rate of 2 patients per month.
measure: Number of participants with treatment allocation change.
time frame: 48 hours from treatment initiation
description: The predefined target is that at least 80% of the participants remain within their assigned treatment group, and not changing treatment allocation for any reason.
measure: Number of participants with any intracranial hemorrhage.
time frame: 24±12 hours from treatment initiation
description: As identified in the follow-up computed tomography scan.
measure: Absolute difference in flow velocity measurements in transcranial Doppler.
time frame: 0-18 hours from treatment initiation
description: Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination.
measure: Absolute difference in the NIH Stroke Scale change at day 1.
time frame: 24±12 hours from treatment initiation
description: NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
measure: Absolute difference in the NIH Stroke Scale change at day 2.
time frame: 48±12 hours from treatment initiation
description: NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
measure: Absolute difference in mean systolic blood pressure values.
time frame: 48 hours from treatment initiation
description: Difference in mean systolic blood pressure values between the two arms.
measure: Number of participants with symptomatic intracranial hemorrhage.
time frame: 24±12 hours from treatment initiation
description: According to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST), National Institute of Neurological Disorders and Stroke (NINDS) and European-Australian Cooperative Acute Stroke Study 2 (ECASS 2) definitions.
measure: Number of deaths during hospitalization.
time frame: Day 7 from treatment initiation or hospital discharge
description: All-cause in-hospital mortality.
measure: Number of deaths during follow-up.
time frame: Day 90±10 from treatment initiation
description: All-cause mortality.
measure: Number of participants with neurological deterioration.
time frame: 24 hours from treatment initiation
description: Defined as ≥4 points decline in the National Institute of Health Stroke Scale (NIHSS) from randomization or death.
measure: Functional outcome during hospitalization.
time frame: Day 7 from treatment initiation or hospital discharge
description: Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).
measure: Functional outcome during follow-up.
time frame: Day 90±10 from treatment initiation
description: Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).
measure: Number of participants with favorable functional outcomes during hospitalization.
time frame: Day 7 from treatment initiation or hospital discharge
description: Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.
measure: Number of participants with favorable functional outcomes during follow-up
time frame: Day 90±10 from treatment initiation
description: Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.
measure: Absolute difference in the decline of the Alberta stroke program early CT scores.
time frame: 24±12 hours from treatment initiation
description: The Alberta Stroke Program Early CT Score (ASPECTS) is a 10-point (range 0-10) quantitative topographic imaging scale with higher scores indicating more favorable imaging profiles. Differences will be assessed between the baseline and repeat computed tomography scan.
measure: Absolute difference in final infarct volumes.
time frame: Day 7 from treatment initiation
description: As assessed in the magnetic resonance imaging (MRI) scan, when available.
measure: Absolute difference in hospital stay.
time frame: Day 7 from treatment initiation or hospital discharge
description: Duration of hospital length of stay in days.
arm group label: Intensive Blood Pressure management
arm group type: Experimental
description: Participants assigned to the intensive blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 140 mmHg for the first 48 hours after enrollment into the study.
arm group label: Standard Blood Pressure management
arm group type: Active Comparator
description: Participants assigned to the standard blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 180 mmHg for the first 48 hours after enrollment into the study.
intervention type: Drug
intervention name: Labetalol
description: 10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
arm group label: Intensive Blood Pressure management
arm group label: Standard Blood Pressure management
intervention type: Drug
intervention name: Hydralazine
description: 10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
arm group label: Intensive Blood Pressure management
arm group label: Standard Blood Pressure management
intervention type: Drug
intervention name: Enalapril
description: 1.25 - 2.5 mg IV bolus and then q6h PRN.
arm group label: Intensive Blood Pressure management
arm group label: Standard Blood Pressure management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aristeidis H Katsanos, MD
role: Principal Investigator
affiliation: Hamilton General Hospital, Hamilton Health Sciences
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Stroke
mesh term: Enalapril
mesh term: Labetalol
mesh term: Hydralazine
sharing ipd: Yes