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/NCT05989581</url>
    </required_header>
    <id_info>
      <org_study_id>3000010726</org_study_id>
      <nct_id>NCT05989581</nct_id>
    </id_info>
    <brief_title>Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project</brief_title>
    <acronym>CHAP2</acronym>
    <official_title>Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</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 CHAP2 study is designed to provide preliminary data for a larger multicenter study to&#xD;
        assess whether treatment of stage 1 hypertension (HTN) in pregnancy improve maternal and or&#xD;
        neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN&#xD;
        treatment to BP&lt;130/80mmHg in pregnant patients with stage 1 HTN is associated with a&#xD;
        difference in birthweight percentile at delivery. Patients with stage 1 hypertension in&#xD;
        pregnancy will be randomized to BP goals of &lt;130/80mmHg or usual care to treatment only if&#xD;
        BPs ≥140/90mmHg. For this pilot, we will randomize a total of 74 eligible participants, 37 to&#xD;
        active treatment to BP&lt;130/80mmHg and 37 to usual care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>Patients with stage 1 HTN in pregnancy will be randomized to BP goals of &lt;130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, we will randomize a total of 74 eligible participants, 37 to active treatment to BP&lt;130/80mmHg and 37 to usual care.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neonatal Birthweight percentile</measure>
      <time_frame>at delivery of infant</time_frame>
      <description>To determine whether anti-HTN treatment to BP&lt;130/80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maternal blood pressure</measure>
      <time_frame>prenatal, delivery, postpartum up to 6 weeks after delivery</time_frame>
      <description>Systolic and diastolic blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gestational age at delivery</measure>
      <time_frame>prenatal, delivery, postpartum up to 6 weeks after delivery</time_frame>
      <description>Gestational age at delivery, preterm birth &lt;37 weeks' gestation, preterm birth&lt;34 weeks' gestation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hypertensive disorders of pregnancy</measure>
      <time_frame>prenatal, delivery, postpartum up to 6 weeks after delivery</time_frame>
      <description>Preeclampsia, eclampsia, gestational hypertension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal adverse cardiovascular composite</measure>
      <time_frame>prenatal, delivery, postpartum up to 6 weeks after delivery</time_frame>
      <description>Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Hypertension in Pregnancy</condition>
    <arm_group>
      <arm_group_label>BP goal &lt;130/80mmHg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BP goal &lt;140/90 (usual care)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BP &lt;130/80mmHg</intervention_name>
      <description>The choice of anti-HTN will be based on the patient and provider's experience and preference. First line anti-HTN recommended in pregnancy- labetalol or nifedipine- will be administered to patients. At least weekly, a study team member will review the participants' BPs and, if randomized to intervention and a higher dose is needed to maintain BPs &lt;130/80 mmHg, the study team member will communicate with the clinical team, led by a University of Alabama Maternal Fetal Medicine Attending, in order to ensure coordination between the research and clinical care teams. Labetalol will be initiated at 200 mg twice daily and escalated in 200mg /dose daily until BP&lt;130/80mmHg to a maximum dose of 2400mg/day. Procardia will be initiated at 30mg XL once daily and uptitrated in 30mg increments until a maximum dose of 120mg daily. Postpartum, titration will occur in similar fashion. The patient will be transitioned to her primary care provider for BP management after the 6-week postpartum visit.</description>
      <arm_group_label>BP goal &lt;130/80mmHg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Viable singleton gestation&#xD;
  &#xD;
            -  No fetal anomalies&#xD;
  &#xD;
            -  Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20&#xD;
               weeks gestation&#xD;
  &#xD;
            -  Planning to deliver at UAB Hospital&#xD;
  &#xD;
            -  No indication for pregnancy termination&#xD;
  &#xD;
            -  Receiving care at the UAB prenatal clinics&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Declines Randomization&#xD;
  &#xD;
            -  Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive&#xD;
               medication use&#xD;
  &#xD;
            -  Fetal demise diagnosed prior to enrollment&#xD;
  &#xD;
            -  Known major structural of chromosomal abnormalities prior to enrollment&#xD;
  &#xD;
            -  Contraindication to first line antihypertensive (Nifedipine/ Labetalol)&#xD;
  &#xD;
            -  Comorbidities requiring BP goals &lt; 130/80mmHg&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Donna Dunn, PhD</last_name>
      <phone>12058739503</phone>
      <email>dcampbell@uabmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jhana Plump</last_name>
      <email>jplump@uabmc.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>Ayodeji Sanusi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
      <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>
  
  
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/NCT05989581
  org study id: 3000010726
  nct id: NCT05989581
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The CHAP2 study is designed to provide preliminary data for a larger multicenter study to
        assess whether treatment of stage 1 hypertension (HTN) in pregnancy improve maternal and or
        neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN
        treatment to BP<130/80mmHg in pregnant patients with stage 1 HTN is associated with a
        difference in birthweight percentile at delivery. Patients with stage 1 hypertension in
        pregnancy will be randomized to BP goals of <130/80mmHg or usual care to treatment only if
        BPs ≥140/90mmHg. For this pilot, we will randomize a total of 74 eligible participants, 37 to
        active treatment to BP<130/80mmHg and 37 to usual care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients with stage 1 HTN in pregnancy will be randomized to BP goals of <130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, we will randomize a total of 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Neonatal Birthweight percentile
  time frame: at delivery of infant
  description: To determine whether anti-HTN treatment to BP<130/80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery
  measure: Maternal blood pressure
  time frame: prenatal, delivery, postpartum up to 6 weeks after delivery
  description: Systolic and diastolic blood pressure
  measure: Gestational age at delivery
  time frame: prenatal, delivery, postpartum up to 6 weeks after delivery
  description: Gestational age at delivery, preterm birth <37 weeks' gestation, preterm birth<34 weeks' gestation
  measure: Hypertensive disorders of pregnancy
  time frame: prenatal, delivery, postpartum up to 6 weeks after delivery
  description: Preeclampsia, eclampsia, gestational hypertension
  measure: Maternal adverse cardiovascular composite
  time frame: prenatal, delivery, postpartum up to 6 weeks after delivery
  description: Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death
  arm group label: BP goal <130/80mmHg
  arm group type: Experimental
  arm group label: BP goal <140/90 (usual care)
  arm group type: No Intervention
  intervention type: Drug
  intervention name: BP <130/80mmHg
  description: The choice of anti-HTN will be based on the patient and provider's experience and preference. First line anti-HTN recommended in pregnancy- labetalol or nifedipine- will be administered to patients. At least weekly, a study team member will review the participants' BPs and, if randomized to intervention and a higher dose is needed to maintain BPs <130/80 mmHg, the study team member will communicate with the clinical team, led by a University of Alabama Maternal Fetal Medicine Attending, in order to ensure coordination between the research and clinical care teams. Labetalol will be initiated at 200 mg twice daily and escalated in 200mg /dose daily until BP<130/80mmHg to a maximum dose of 2400mg/day. Procardia will be initiated at 30mg XL once daily and uptitrated in 30mg increments until a maximum dose of 120mg daily. Postpartum, titration will occur in similar fashion. The patient will be transitioned to her primary care provider for BP management after the 6-week postpartum visit.
  arm group label: BP goal <130/80mmHg
  criteria: 
  gender: Female
  minimum age: 14 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Donna Dunn, PhD
  phone: 12058739503
  email: dcampbell@uabmc.edu
  last name: Jhana Plump
  email: jplump@uabmc.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Ayodeji Sanusi
  investigator title: Principal Investigator
  mesh term: Hypertension, Pregnancy-Induced
  mesh term: Hypertension
  sharing ipd: No