<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/NCT02220023</url>
  </required_header>
  <id_info>
    <org_study_id>140068</org_study_id>
    <nct_id>NCT02220023</nct_id>
  </id_info>
  <brief_title>Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI</brief_title>
  <acronym>iNO</acronym>
  <official_title>Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mallinckrodt</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and&#xD;
      pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with&#xD;
      pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on&#xD;
      invasive catheterization as well as healthy subjects. Measurements will also be made after&#xD;
      high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The&#xD;
      investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to&#xD;
      measure dynamic changes in RV-pulmonary vascular function in patients with&#xD;
      vasodilator-responsive PAH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Early Phase 1</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure</measure>
    <time_frame>At time of procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary flow</measure>
    <time_frame>Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary perfusion</measure>
    <time_frame>Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimates of pulmonary vascular resistance</measure>
    <time_frame>At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary transit time</measure>
    <time_frame>At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary artery compliance</measure>
    <time_frame>At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Pulmonary Vascular Disorder</condition>
  <arm_group>
    <arm_group_label>Nitric Oxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 ppm, one time administration, inhaled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INOmax Inhalation</intervention_name>
    <arm_group_label>Nitric Oxide</arm_group_label>
    <other_name>nitric oxide</other_name>
    <other_name>NDA 20-845</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 or older of the Vanderbilt Center for Pulmonary Vascular Disease.&#xD;
             Vasodilator-responsive patients will be identified based on prior response to inhaled&#xD;
             nitric oxide during invasive right heart catheterization&#xD;
&#xD;
          -  Healthy subjects age 18 or older not known to have cardiopulmonary disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Standard conventional contraindications for cardiac magnetic resonance (CMR) imaging&#xD;
&#xD;
          -  Allergy or contraindication to Magnevist (gadopentetate dimeglumine) contrast&#xD;
&#xD;
          -  Concurrent intravenous epoprostenol infusion in whom performance of CMR is cumbersome&#xD;
&#xD;
          -  Pregnant women&#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>Evan L Brittain, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>February 10, 2017</last_update_submitted>
  <last_update_submitted_qc>February 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Evan Brittain</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>Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</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/NCT02220023
org study id: 140068
nct id: NCT02220023
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and
      pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with
      pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on
      invasive catheterization as well as healthy subjects. Measurements will also be made after
      high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The
      investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to
      measure dynamic changes in RV-pulmonary vascular function in patients with
      vasodilator-responsive PAH.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
time frame: At time of procedure
measure: Pulmonary flow
time frame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
measure: Pulmonary perfusion
time frame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
measure: Estimates of pulmonary vascular resistance
time frame: At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
measure: Pulmonary transit time
time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
measure: Pulmonary artery compliance
time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
arm group label: Nitric Oxide
arm group type: Experimental
description: 40 ppm, one time administration, inhaled.
intervention type: Drug
intervention name: INOmax Inhalation
arm group label: Nitric Oxide
other name: nitric oxide
other name: NDA 20-845
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evan L Brittain, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Evan Brittain
investigator title: Assistant Professor
mesh term: Vascular Diseases
mesh term: Nitric Oxide