<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/NCT02188082</url>
  </required_header>
  <id_info>
    <org_study_id>LSQYFBLDHF2013</org_study_id>
    <nct_id>NCT02188082</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）</brief_title>
  <acronym>FIRST</acronym>
  <official_title>Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of&#xD;
      sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of&#xD;
      IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to&#xD;
      severe chronic systolic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram</measure>
    <time_frame>baseline and week 32</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in distance of 6-minute walking test</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in heart rate</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in scores of Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in NT-proBNP</measure>
    <time_frame>baseline and week 32</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">336</enrollment>
  <condition>Chronic Systolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>IvabRadine hemisulfate Sustained-release Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-15mg qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5-15mg qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IvabRadine hemisulfate Sustained-release Tablets</intervention_name>
    <arm_group_label>IvabRadine hemisulfate Sustained-release Tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged from 18 to 75 years, males or females&#xD;
&#xD;
          -  Willing to provide written informed consent&#xD;
&#xD;
          -  NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for&#xD;
&#xD;
             ≥4 weeks&#xD;
&#xD;
          -  Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks&#xD;
&#xD;
          -  Sinus rhythm with resting heart rate≥70 b.p.m.&#xD;
&#xD;
          -  Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within&#xD;
             previous 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiovascular condition(for example, hospital admission for worsening heart&#xD;
             failure)&#xD;
&#xD;
          -  Recent (&lt;2 months) myocardial infarction or recent or scheduled coronary&#xD;
             revascularization&#xD;
&#xD;
          -  Stroke or transient cerebral ischaemia within previous 4 weeks&#xD;
&#xD;
          -  Severe primary valvular disease&#xD;
&#xD;
          -  Scheduled surgery of valvular heart disease&#xD;
&#xD;
          -  Active myocarditis&#xD;
&#xD;
          -  Congenital heart diseases&#xD;
&#xD;
          -  peripartum cardiomyopathy&#xD;
&#xD;
          -  hyperthyroid heart disease&#xD;
&#xD;
          -  On list for cardiac transplantation&#xD;
&#xD;
          -  Cardiac resynchronization therapy started within previous 6 months&#xD;
&#xD;
          -  Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the&#xD;
             time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.&#xD;
&#xD;
          -  Permanent atrial fibrillation or flutter&#xD;
&#xD;
          -  Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular block&#xD;
&#xD;
          -  History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a&#xD;
             cardioverter/defibrillator implanted&#xD;
&#xD;
          -  Cardioverter/defibrillator shock within previous 6 months&#xD;
&#xD;
          -  Family history or congenital long QT syndrome or treated with selected QT-prolonging&#xD;
             products(except amiodarone)&#xD;
&#xD;
          -  Contraindication or intolerance to ivabradine or lactulose&#xD;
&#xD;
          -  Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)&#xD;
&#xD;
          -  known anaemia(Hb&lt;100 g/L)&#xD;
&#xD;
          -  Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal&#xD;
             disease(Cr˃2ULN)&#xD;
&#xD;
          -  Pregnant or lactating women and women planning to become pregnant&#xD;
&#xD;
          -  Use of an investigational drug within 30 days of enrollment&#xD;
&#xD;
          -  Has a history of psychological illness/condition that interferes with ability to&#xD;
             understand or complete requirements of the study&#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>Jianan Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianan Wang, doctor</last_name>
    <phone>0571-87315001</phone>
    <email>wang_jian_an@tom.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The military general hospitla of Beijing PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Junxia Li</last_name>
    </contact>
    <investigator>
      <last_name>Junxia Li</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital of suzhou university</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yang Jiao</last_name>
    </contact>
    <investigator>
      <last_name>Yang Jiao</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Subei People's Hospital of Jiangsu province</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiang Gu</last_name>
    </contact>
    <investigator>
      <last_name>Xiang Gu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>the First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yu Zhang</last_name>
    </contact>
    <investigator>
      <last_name>Yu Zhang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>shengjing hospital of China medical university</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shumei Ma</last_name>
    </contact>
    <investigator>
      <last_name>Shumei Ma</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ming Zhong</last_name>
    </contact>
    <investigator>
      <last_name>Ming Zhong</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>the Second Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qinghua Lu</last_name>
    </contact>
    <investigator>
      <last_name>Qinghu Lu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of zhejiang university school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiaosheng Hu</last_name>
    </contact>
    <investigator>
      <last_name>Xiaosheng Hu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hangzhou First People'S Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yizhou Xu</last_name>
    </contact>
    <investigator>
      <last_name>Yizhou Xu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital of zhejiang university school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianan Wang, doctor</last_name>
    </contact>
    <investigator>
      <last_name>Jianan Wang, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of wenzhou medical university</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Weijian Huang</last_name>
    </contact>
    <investigator>
      <last_name>Weijian Huang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital of wenzhou medical university</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jifei Tang</last_name>
    </contact>
    <investigator>
      <last_name>Jifei Tang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</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>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_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/NCT02188082
org study id: LSQYFBLDHF2013
nct id: NCT02188082
lead sponsor: 
has dmc: No
Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of
      sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of
      IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to
      severe chronic systolic heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
time frame: baseline and week 32
measure: Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
time frame: baseline and week 32
measure: incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
time frame: baseline and week 32
measure: change from baseline in distance of 6-minute walking test
time frame: baseline and week 32
measure: change from baseline in heart rate
time frame: baseline and week 32
measure: change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
time frame: baseline and week 32
measure: change from baseline in NT-proBNP
time frame: baseline and week 32
arm group label: IvabRadine hemisulfate Sustained-release Tablets
arm group type: Experimental
description: 5-15mg qd
arm group label: placebo
arm group type: Placebo Comparator
description: 5-15mg qd
intervention type: Drug
intervention name: IvabRadine hemisulfate Sustained-release Tablets
arm group label: IvabRadine hemisulfate Sustained-release Tablets
intervention type: Drug
intervention name: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianan Wang, Doctor
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Jianan Wang, doctor
phone: 0571-87315001
email: wang_jian_an@tom.com
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Systolic Murmurs