<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/NCT02251509</url>
  </required_header>
  <id_info>
    <org_study_id>624918</org_study_id>
    <nct_id>NCT02251509</nct_id>
  </id_info>
  <brief_title>Rate Control in Atrial Fibrillation</brief_title>
  <official_title>Rate Control in Atrial Fibrillation: A Randomized, Double-Blind, Crossover Comparison of Carvedilol and Metoprolol Tartrate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Creighton University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creighton University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart&#xD;
      rate control in patients with atrial fibrillation and a rapid ventricular rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting heart rate</measure>
    <time_frame>2 weeks</time_frame>
    <description>Resting heart rate less than 80 bpm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Carvedilol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>carvedilol BID for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metoprolol tartrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metoprolol tartrate BID for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carvedilol</intervention_name>
    <arm_group_label>Carvedilol</arm_group_label>
    <other_name>Coreg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol tartrate</intervention_name>
    <arm_group_label>Metoprolol tartrate</arm_group_label>
    <other_name>Lopressor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Permanent atrial fibrillation&#xD;
&#xD;
          -  Baseline ventricular rate (prior to treatment) &gt; 110 bpm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of accessory tract re-entry tachycardia&#xD;
&#xD;
          -  Ejection fraction &lt; 35% or history of NYHA Class III/IV stage C/D heart failure&#xD;
&#xD;
          -  Acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery in the&#xD;
             past 2 months&#xD;
&#xD;
          -  Child-Pugh class B or C hepatic dysfunction&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Intolerance to beta-blockers&#xD;
&#xD;
          -  History of lung disease resulting in hospitalization in the past year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pallavi Bellamkonda, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Creighton University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caroline Nubel</last_name>
    <phone>(402) 280-4032</phone>
    <email>carolinenubel@creighton.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68178</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Caroline Nubel</last_name>
      <phone>402-280-4032</phone>
      <email>carolinenubel@creighton.edu</email>
    </contact>
    <investigator>
      <last_name>Pallavi Bellamkonda, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>June 15, 2016</last_update_submitted>
  <last_update_submitted_qc>June 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2016</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoprolol</mesh_term>
    <mesh_term>Carvedilol</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/NCT02251509
org study id: 624918
nct id: NCT02251509
lead sponsor: 
has dmc: No
This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart
      rate control in patients with atrial fibrillation and a rapid ventricular rate.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Resting heart rate
time frame: 2 weeks
description: Resting heart rate less than 80 bpm
arm group label: Carvedilol
arm group type: Experimental
description: carvedilol BID for 2 weeks
arm group label: Metoprolol tartrate
arm group type: Experimental
description: Metoprolol tartrate BID for 2 weeks
intervention type: Drug
intervention name: Carvedilol
arm group label: Carvedilol
other name: Coreg
intervention type: Drug
intervention name: Metoprolol tartrate
arm group label: Metoprolol tartrate
other name: Lopressor
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Pallavi Bellamkonda, MBBS
role: Principal Investigator
affiliation: Creighton University
last name: Caroline Nubel
phone: (402) 280-4032
email: carolinenubel@creighton.edu
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Metoprolol
mesh term: Carvedilol