<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/NCT03235700</url>
  </required_header>
  <id_info>
    <org_study_id>1642</org_study_id>
    <nct_id>NCT03235700</nct_id>
  </id_info>
  <brief_title>Hyperemic Efficacy of IV Adenosine in HFrEF</brief_title>
  <acronym>HF-FFR</acronym>
  <official_title>Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sejong General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sejong General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients&#xD;
      with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the&#xD;
      major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in&#xD;
      patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment&#xD;
      using a coronary pressure wire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients&#xD;
      with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the&#xD;
      major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in&#xD;
      patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment&#xD;
      using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70%&#xD;
      diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection&#xD;
      fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation&#xD;
      using IV adenosine 140 &amp; 180, IC adenosine, and IC nicorandil will be measured sequentially.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure to induce maximal hyperemia</measure>
    <time_frame>less than 1 day</time_frame>
    <description>no hyperemia, cyclic hyperemia, and submaximal hyperemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fractional flow reserve</measure>
    <time_frame>less than 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to maximal hyperemia</measure>
    <time_frame>less than 1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Heart Failure With Reduced Ejection Fraction</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Adenosine followed by nicorandil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicorandil followed by adenosine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maximal hyperemia with adenosine followed by nicorandil</intervention_name>
    <description>IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2</description>
    <arm_group_label>Adenosine followed by nicorandil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maximal hyperemia with nicorandil followed by adenosine</intervention_name>
    <description>IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)</description>
    <arm_group_label>Nicorandil followed by adenosine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  angiographically proven epicardial intermediate stenosis (40-70%)&#xD;
&#xD;
          -  echocardiographically proven LV dysfunction (LVEF ≤40%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infarct-related artery, less than 2 weeks&#xD;
&#xD;
          -  Killip class 3 and 4&#xD;
&#xD;
          -  bronchial asthma&#xD;
&#xD;
          -  second degree or third degree AV block&#xD;
&#xD;
          -  any contraindications to adenosine&#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_contact>
    <last_name>Ho-Jun Jang, MD</last_name>
    <phone>+82-32-340-1445</phone>
    <email>hojunjang77@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi</state>
        <zip>422-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyun-Jong Lee, MD</last_name>
      <phone>82-10-6217-9315</phone>
      <email>untouchables@sejongh.co.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure with reduced ejection fraction</keyword>
  <keyword>intermediate coronary stenosis</keyword>
  <keyword>adenosine</keyword>
  <keyword>hyperemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicorandil</mesh_term>
    <mesh_term>Adenosine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03235700
org study id: 1642
nct id: NCT03235700
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients
      with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the
      major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in
      patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment
      using a coronary pressure wire.
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients
      with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the
      major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in
      patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment
      using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70%
      diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection
      fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation
      using IV adenosine 140 & 180, IC adenosine, and IC nicorandil will be measured sequentially.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Failure to induce maximal hyperemia
time frame: less than 1 day
description: no hyperemia, cyclic hyperemia, and submaximal hyperemia
measure: Fractional flow reserve
time frame: less than 1 day
measure: time to maximal hyperemia
time frame: less than 1 day
arm group label: Adenosine followed by nicorandil
arm group type: Experimental
arm group label: Nicorandil followed by adenosine
arm group type: Experimental
intervention type: Other
intervention name: Maximal hyperemia with adenosine followed by nicorandil
description: IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
arm group label: Adenosine followed by nicorandil
intervention type: Other
intervention name: Maximal hyperemia with nicorandil followed by adenosine
description: IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
arm group label: Nicorandil followed by adenosine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ho-Jun Jang, MD
phone: +82-32-340-1445
email: hojunjang77@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Coronary Artery Disease
mesh term: Nicorandil
mesh term: Adenosine
sharing ipd: Undecided