<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/NCT04473807</url>
  </required_header>
  <id_info>
    <org_study_id>KCHRF-DASH-AF-0002</org_study_id>
    <nct_id>NCT04473807</nct_id>
  </id_info>
  <brief_title>Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy</brief_title>
  <acronym>DASH-AF</acronym>
  <official_title>Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation (DASH-AF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Munson Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kansas City Heart Rhythm Research Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and feasibility of the IV loading&#xD;
      strategy in patients who are selected to receive sotalol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label single arm study investigating the safety and feasibility of an&#xD;
      intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed&#xD;
      Consent will be obtained from all patients prior to enrollment in the study. Patients will be&#xD;
      admitted to the hospital in accordance with standard hospital protocol for oral sotalol&#xD;
      loading.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2021</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intravenous loading regimen followed by q12h oral sotalol administration</measure>
    <time_frame>3 months</time_frame>
    <description>The hypothesis to be tested is that the intravenous loading regimen followed by q12h oral sotalol administration will result in sotalol concentration and QTc peaks on day 1 (IV to oral loading) which are comparable to the steady-state and maximum QTc seen on Day 3 (steady-state).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>DASH-AF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with history of highly symptomatic persistent or paroxysmal AF who are scheduled for sotalol therapy once in sinus rhythm will be enrolled in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation</intervention_name>
    <description>The hypothesis to be tested is that the intravenous loading regimen followed by oral sotalol administration 4 hours after the conclusion of the IV infusion (every 12 hours thereafter) will result in sotalol peak concentrations at the end of IV loading dose (IV to oral loading) which are comparable to the steady state and maximum QTc seen on Day 3 after the last in-hospital oral dose.</description>
    <arm_group_label>DASH-AF</arm_group_label>
    <other_name>Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female between 18 - 85 years old&#xD;
&#xD;
          -  Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol&#xD;
             therapy&#xD;
&#xD;
          -  History of highly symptomatic atrial fibrillation who are scheduled for sotalol&#xD;
             therapy&#xD;
&#xD;
          -  Creatinine clearance ≥60 mL/min&#xD;
&#xD;
          -  Subject has provided informed consent prior to initiation of any study-specific&#xD;
             activities/procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baseline bradycardia (&lt;50 bpm) off all antiarrhythmic drugs and or Atrioventricular&#xD;
             nodal blocking drugs&#xD;
&#xD;
          -  Sick sinus syndrome, unless a functioning pacemaker is present.&#xD;
&#xD;
          -  Any known sensitivities to beta-blockers&#xD;
&#xD;
          -  Uncontrolled heart failure&#xD;
&#xD;
          -  Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block&#xD;
&#xD;
          -  Recent (within 7 days) surgical or catheter ablation procedure&#xD;
&#xD;
          -  Severe electrolyte abnormalities (including serum K&lt;3.5)&#xD;
&#xD;
          -  Known use of other QTc prolonging drugs (See Appendix A)&#xD;
&#xD;
          -  Recent (within 7 days) sotalol use&#xD;
&#xD;
          -  Baseline QTc &gt;450 ms&#xD;
&#xD;
          -  Severe reactive airway disease - defined as difficulty breathing from bronchial tubes,&#xD;
             swelling and overreaction to an irritant&#xD;
&#xD;
          -  History of Torsade de Pointes (TdP)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) less than 35%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Research Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donita Atkins</last_name>
    <phone>816-651-1969</phone>
    <email>datkins@kchrf.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donita Atkins</last_name>
      <phone>816-651-1969</phone>
      <email>datkins@kchrf.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Boriani G, Valzania C, Biffi M, Corazza I, Camanini C, Martignani C, Bacchi L, Zannoli R, Branzi A. Increase in QT/QTc dispersion after low energy cardioversion of chronic persistent atrial fibrillation. Int J Cardiol. 2004 Jun;95(2-3):245-50. doi: 10.1016/j.ijcard.2003.05.022.</citation>
    <PMID>15193827</PMID>
  </reference>
  <reference>
    <citation>Darbar D, Hardin B, Harris P, Roden DM. A rate-independent method of assessing QT-RR slope following conversion of atrial fibrillation. J Cardiovasc Electrophysiol. 2007 Jun;18(6):636-41. doi: 10.1111/j.1540-8167.2007.00817.x. Epub 2007 May 3.</citation>
    <PMID>17488270</PMID>
  </reference>
  <reference>
    <citation>HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.</citation>
  </reference>
  <reference>
    <citation>Woosley RL, Heise CW, Tate J, Woosley D, Romero KA, Gallo T. QTdrugs List. https://crediblemeds.org/index.php/?cID=328. Accessed August 28, 2019.</citation>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>December 28, 2021</last_update_submitted>
  <last_update_submitted_qc>December 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sotalol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04473807
org study id: KCHRF-DASH-AF-0002
nct id: NCT04473807
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and feasibility of the IV loading
      strategy in patients who are selected to receive sotalol.
This is an open-label single arm study investigating the safety and feasibility of an
      intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed
      Consent will be obtained from all patients prior to enrollment in the study. Patients will be
      admitted to the hospital in accordance with standard hospital protocol for oral sotalol
      loading.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: intravenous loading regimen followed by q12h oral sotalol administration
time frame: 3 months
description: The hypothesis to be tested is that the intravenous loading regimen followed by q12h oral sotalol administration will result in sotalol concentration and QTc peaks on day 1 (IV to oral loading) which are comparable to the steady-state and maximum QTc seen on Day 3 (steady-state).
arm group label: DASH-AF
arm group type: Other
description: Patients with history of highly symptomatic persistent or paroxysmal AF who are scheduled for sotalol therapy once in sinus rhythm will be enrolled in this study.
intervention type: Drug
intervention name: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
description: The hypothesis to be tested is that the intravenous loading regimen followed by oral sotalol administration 4 hours after the conclusion of the IV infusion (every 12 hours thereafter) will result in sotalol peak concentrations at the end of IV loading dose (IV to oral loading) which are comparable to the steady state and maximum QTc seen on Day 3 after the last in-hospital oral dose.
arm group label: DASH-AF
other name: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dhanunjaya Lakkireddy
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Research Foundation
last name: Donita Atkins
phone: 816-651-1969
email: datkins@kchrf.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Boriani G, Valzania C, Biffi M, Corazza I, Camanini C, Martignani C, Bacchi L, Zannoli R, Branzi A. Increase in QT/QTc dispersion after low energy cardioversion of chronic persistent atrial fibrillation. Int J Cardiol. 2004 Jun;95(2-3):245-50. doi: 10.1016/j.ijcard.2003.05.022.
PMID: 15193827
citation: Darbar D, Hardin B, Harris P, Roden DM. A rate-independent method of assessing QT-RR slope following conversion of atrial fibrillation. J Cardiovasc Electrophysiol. 2007 Jun;18(6):636-41. doi: 10.1111/j.1540-8167.2007.00817.x. Epub 2007 May 3.
PMID: 17488270
citation: HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
citation: Woosley RL, Heise CW, Tate J, Woosley D, Romero KA, Gallo T. QTdrugs List. https://crediblemeds.org/index.php/?cID=328. Accessed August 28, 2019.
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
mesh term: Sotalol
sharing ipd: No