<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/NCT03830957</url>
  </required_header>
  <id_info>
    <org_study_id>HFRC_01</org_study_id>
    <nct_id>NCT03830957</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker</brief_title>
  <official_title>Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rajaie Cardiovascular Medical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rajaie Cardiovascular Medical and Research Center</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart&#xD;
      rate prior to coronary CT angiography in patients with advanced heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>30 minutes before and after coronary CT angiography</time_frame>
    <description>Changing heart rate during imaging study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>30 minutes before and after coronary CT angiography and 6 months later</time_frame>
    <description>Shortness of breath, or &quot;dyspnea&quot;, is the most famous symptom of left ventricular failure. It typically appears during strenuous activities, and progresses to ordinary activities, less than ordinary activities and ultimately resting state. The severity is categorized as above (FC 1 to 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional calss</measure>
    <time_frame>30 minutes before and after coronary CT angiography and 6 months later</time_frame>
    <description>Heart Failure severity has been classified according to New York Heart Association (NYHA) to:&#xD;
Class I: No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.&#xD;
Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.&#xD;
Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.&#xD;
Class IV: Unable to perform any physical activity without symptoms of HF, or symptoms of HF at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure, systolic and diastolic</measure>
    <time_frame>30 minutes before and after coronary CT angiography and 6 months later</time_frame>
    <description>The amount of blood pressure measured by sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Before CT angiography and 6 months later</time_frame>
    <description>The rate of disturbed sleep measured as better than before, Worse than before, and No change&#xD;
There are no standard classification for severity of this symptom. In our study, we measure this symptom as :&#xD;
Better than before (1)&#xD;
Worse than before (2)&#xD;
No change (0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>Before CT angiography and 6 months later</time_frame>
    <description>The rate of changing in appetite level measured as better than before, Worse than before, and No change&#xD;
Loss of appetite is a common symptom of heart failure. There are no standard classification for severity of this symptom. In our study, we measure this symptom as :&#xD;
Better than before (1)&#xD;
Worse than before (2)&#xD;
No change (0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged bradycardia</measure>
    <time_frame>30 minutes before and after coronary CT angiography</time_frame>
    <description>Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>30 minutes before and after coronary CT angiography</time_frame>
    <description>Systolic less than 80 mm Hg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Heart Failure</condition>
  <condition>CT Angiography</condition>
  <condition>Ischemic Cardiomyopathy</condition>
  <condition>Non-ischemic Cardiomyopathy</condition>
  <condition>Heart Failure, Systolic</condition>
  <condition>Heart Failure，Congestive</condition>
  <condition>Heart Failure, Diastolic</condition>
  <condition>Heart Rate Low</condition>
  <arm_group>
    <arm_group_label>Ivabradine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>metoprolol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivabradine</intervention_name>
    <description>7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg</description>
    <arm_group_label>Ivabradine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol</intervention_name>
    <description>5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg</description>
    <arm_group_label>metoprolol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sinus rhythm&#xD;
&#xD;
          -  Heart rate &gt;60/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Any contraindication for beta-blocker use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ahmad Amin</name>
      <address>
        <city>Tehran</city>
        <zip>1996911151</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad Amin, MD</last_name>
      <phone>+98 21 2392</phone>
      <phone_ext>2172</phone_ext>
      <email>amina33@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</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>Cardiomyopathies</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Heart Failure, Diastolic</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoprolol</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/NCT03830957
org study id: HFRC_01
nct id: NCT03830957
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart
      rate prior to coronary CT angiography in patients with advanced heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Heart rate
time frame: 30 minutes before and after coronary CT angiography
description: Changing heart rate during imaging study
measure: Dyspnea
time frame: 30 minutes before and after coronary CT angiography and 6 months later
description: Shortness of breath, or "dyspnea", is the most famous symptom of left ventricular failure. It typically appears during strenuous activities, and progresses to ordinary activities, less than ordinary activities and ultimately resting state. The severity is categorized as above (FC 1 to 4)
measure: Functional calss
time frame: 30 minutes before and after coronary CT angiography and 6 months later
description: Heart Failure severity has been classified according to New York Heart Association (NYHA) to:
Class I: No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.
Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.
Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.
Class IV: Unable to perform any physical activity without symptoms of HF, or symptoms of HF at rest.
measure: Blood pressure, systolic and diastolic
time frame: 30 minutes before and after coronary CT angiography and 6 months later
description: The amount of blood pressure measured by sphygmomanometer
measure: Sleep quality
time frame: Before CT angiography and 6 months later
description: The rate of disturbed sleep measured as better than before, Worse than before, and No change
There are no standard classification for severity of this symptom. In our study, we measure this symptom as :
Better than before (1)
Worse than before (2)
No change (0)
measure: Appetite
time frame: Before CT angiography and 6 months later
description: The rate of changing in appetite level measured as better than before, Worse than before, and No change
Loss of appetite is a common symptom of heart failure. There are no standard classification for severity of this symptom. In our study, we measure this symptom as :
Better than before (1)
Worse than before (2)
No change (0)
measure: Prolonged bradycardia
time frame: 30 minutes before and after coronary CT angiography
description: Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.
measure: Hypotension
time frame: 30 minutes before and after coronary CT angiography
description: Systolic less than 80 mm Hg
arm group label: Ivabradine
arm group type: Active Comparator
arm group label: metoprolol
arm group type: Active Comparator
intervention type: Drug
intervention name: Ivabradine
description: 7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg
arm group label: Ivabradine
intervention type: Drug
intervention name: Metoprolol
description: 5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg
arm group label: metoprolol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiomyopathies
mesh term: Heart Failure, Systolic
mesh term: Heart Failure, Diastolic
mesh term: Bradycardia
mesh term: Metoprolol
sharing ipd: Undecided