<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/NCT02220634</url>
  </required_header>
  <id_info>
    <org_study_id>HS-2820</org_study_id>
    <nct_id>NCT02220634</nct_id>
  </id_info>
  <brief_title>Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension</brief_title>
  <acronym>RHINO</acronym>
  <official_title>Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if Regadenoson may offer improved ease of use, single&#xD;
      dose administration, and better tolerance for testing for pulmonary hypertension than iNO.&#xD;
      You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,&#xD;
      blood tests, and an ECG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary hypertension (PH) is an increase of blood pressure in the pulmonary vascular system&#xD;
      that could cause shortness of breath, dizziness, leg swelling and heart failure. .&#xD;
&#xD;
      The diagnosis of PH requires confirmation of elevated pulmonary pressures.. Right heart&#xD;
      catheterization (RHC) is a procedure to determine the diagnosis of PH. .&#xD;
&#xD;
      This research study is looking at the effect of intravenous infusion of the medication&#xD;
      Regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (iNO)&#xD;
      response. iNO is the current standard of care practice.&#xD;
&#xD;
      The purpose of this study is to see if Regadenoson may offer improved ease of use, single&#xD;
      dose administration, and better tolerance for testing for pulmonary hypertension than iNO.&#xD;
      You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,&#xD;
      blood tests, and an ECG.&#xD;
&#xD;
      You will be asked to sign this informed consent form. Then, you will undergo right heart&#xD;
      catheterization as part of your clinical care. Those who are positive for pulmonary&#xD;
      hypertension will then undergo Regadenoson infusion and a inhaled iNO. Prior to the infusion,&#xD;
      subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or&#xD;
      beverages, caffeine-containing medications such as theophylline 12 hours prior. Vital sign&#xD;
      measurements will be taken to measure your heart. For those subjects that have low heart&#xD;
      volume they will be given 500 cc of normal saline in their IV. Vital sign measurements will&#xD;
      be taken again to make sure your heart volume is in the normal range. The doctor will&#xD;
      administer Regadenoson 0.4 mg intravenously and this will cause your heart rate to increase.&#xD;
      The doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20&#xD;
      minutes after administration. Approximately 30 minutes after the Regadenoson has been&#xD;
      administered you will be given iNO by facemask for 5 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI left National Jewish Health&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of people</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Regadenoson</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion of the A2A agonist regadenoson has a preferential vasodilator effect on pulmonary vasculature that is comparable to iNO, the current gold standard for pulmonary vasoreactivity studies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Regadenoson</intervention_name>
    <description>Injection for intravenous administration</description>
    <arm_group_label>Regadenoson</arm_group_label>
    <other_name>Lexiscan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-75 years old&#xD;
&#xD;
          2. Diagnosis of RHC-proven PH&#xD;
&#xD;
               -  Mean pulmonary artery pressure (mPAP) &gt; 25 mmHg&#xD;
&#xD;
               -  Pulmonary vascular resistance (PVR) &gt; 3 woods units&#xD;
&#xD;
               -  Pulmonary capillary wedge pressure (PCWP) &lt; 15 mmHg).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Second- or third-degree AV block or sinus node dysfunction&#xD;
&#xD;
          2. Known hypersensitivity to adenosine or regadenoson&#xD;
&#xD;
          3. Systolic blood pressure &lt; 90mm Hg&#xD;
&#xD;
          4. Active bronchospasm&#xD;
&#xD;
          5. Autonomic dysfunction as defined by prior diagnosis of:&#xD;
&#xD;
               -  Postural Orthostatic Tachycardia Syndrome (POTS)&#xD;
&#xD;
               -  Neurocardiogenic Syncope (NCS)&#xD;
&#xD;
               -  Neurally Mediated Hypotension (NMH)&#xD;
&#xD;
               -  Vasovagal Syncope&#xD;
&#xD;
          6. Hypovolemia&#xD;
&#xD;
          7. &gt; 40% Left main coronary stenosis&#xD;
&#xD;
          8. Moderate or &gt; valvular stenosis&#xD;
&#xD;
          9. Pericarditis/pericardial effusions&#xD;
&#xD;
         10. &gt; 70% carotid artery stenosis&#xD;
&#xD;
         11. Positive urine pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brett E Fenster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Jewish Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 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, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Regadenoson</mesh_term>
  </intervention_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/NCT02220634
org study id: HS-2820
nct id: NCT02220634
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to see if Regadenoson may offer improved ease of use, single
      dose administration, and better tolerance for testing for pulmonary hypertension than iNO.
      You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,
      blood tests, and an ECG.
Pulmonary hypertension (PH) is an increase of blood pressure in the pulmonary vascular system
      that could cause shortness of breath, dizziness, leg swelling and heart failure. .

      The diagnosis of PH requires confirmation of elevated pulmonary pressures.. Right heart
      catheterization (RHC) is a procedure to determine the diagnosis of PH. .

      This research study is looking at the effect of intravenous infusion of the medication
      Regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (iNO)
      response. iNO is the current standard of care practice.

      The purpose of this study is to see if Regadenoson may offer improved ease of use, single
      dose administration, and better tolerance for testing for pulmonary hypertension than iNO.
      You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,
      blood tests, and an ECG.

      You will be asked to sign this informed consent form. Then, you will undergo right heart
      catheterization as part of your clinical care. Those who are positive for pulmonary
      hypertension will then undergo Regadenoson infusion and a inhaled iNO. Prior to the infusion,
      subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or
      beverages, caffeine-containing medications such as theophylline 12 hours prior. Vital sign
      measurements will be taken to measure your heart. For those subjects that have low heart
      volume they will be given 500 cc of normal saline in their IV. Vital sign measurements will
      be taken again to make sure your heart volume is in the normal range. The doctor will
      administer Regadenoson 0.4 mg intravenously and this will cause your heart rate to increase.
      The doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20
      minutes after administration. Approximately 30 minutes after the Regadenoson has been
      administered you will be given iNO by facemask for 5 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of people
time frame: 5 years
arm group label: Regadenoson
arm group type: Experimental
description: Intravenous infusion of the A2A agonist regadenoson has a preferential vasodilator effect on pulmonary vasculature that is comparable to iNO, the current gold standard for pulmonary vasoreactivity studies.
intervention type: Drug
intervention name: Regadenoson
description: Injection for intravenous administration
arm group label: Regadenoson
other name: Lexiscan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Brett E Fenster, MD
role: Principal Investigator
affiliation: National Jewish Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Regadenoson