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Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy (DASH-AF)

Primary Purpose

Arrhythmias, Cardiac, Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
Sponsored by
Kansas City Heart Rhythm Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arrhythmias, Cardiac focused on measuring Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female between 18 - 85 years old
  • Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy
  • History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy
  • Creatinine clearance ≥60 mL/min
  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures

Exclusion Criteria:

  • Baseline bradycardia (<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs
  • Sick sinus syndrome, unless a functioning pacemaker is present.
  • Any known sensitivities to beta-blockers
  • Uncontrolled heart failure
  • Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block
  • Recent (within 7 days) surgical or catheter ablation procedure
  • Severe electrolyte abnormalities (including serum K<3.5)
  • Known use of other QTc prolonging drugs (See Appendix A)
  • Recent (within 7 days) sotalol use
  • Baseline QTc >450 ms
  • Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant
  • History of Torsade de Pointes (TdP)
  • Pregnancy or breastfeeding
  • Left ventricular ejection fraction (LVEF) less than 35%

Sites / Locations

  • Kansas City Heart Rhythm InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DASH-AF

Arm 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.

Outcomes

Primary Outcome Measures

intravenous loading regimen followed by q12h oral sotalol administration
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).

Secondary Outcome Measures

Full Information

First Posted
July 13, 2020
Last Updated
December 28, 2021
Sponsor
Kansas City Heart Rhythm Research Foundation
Collaborators
Texas Cardiac Arrhythmia Research Foundation, Munson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04473807
Brief Title
Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
Acronym
DASH-AF
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Research Foundation
Collaborators
Texas Cardiac Arrhythmia Research Foundation, Munson Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Atrial Fibrillation
Keywords
Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DASH-AF
Arm Type
Other
Arm 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(s)
Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
Other Intervention Name(s)
Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
intravenous loading regimen followed by q12h oral sotalol administration
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female between 18 - 85 years old Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy Creatinine clearance ≥60 mL/min Subject has provided informed consent prior to initiation of any study-specific activities/procedures Exclusion Criteria: Baseline bradycardia (<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs Sick sinus syndrome, unless a functioning pacemaker is present. Any known sensitivities to beta-blockers Uncontrolled heart failure Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block Recent (within 7 days) surgical or catheter ablation procedure Severe electrolyte abnormalities (including serum K<3.5) Known use of other QTc prolonging drugs (See Appendix A) Recent (within 7 days) sotalol use Baseline QTc >450 ms Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant History of Torsade de Pointes (TdP) Pregnancy or breastfeeding Left ventricular ejection fraction (LVEF) less than 35%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donita Atkins
Phone
816-651-1969
Email
datkins@kchrf.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy
Organizational Affiliation
Kansas City Heart Rhythm Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City Heart Rhythm Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donita Atkins
Phone
816-651-1969
Email
datkins@kchrf.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15193827
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.
Results Reference
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PubMed Identifier
17488270
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.
Results Reference
background
Citation
HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
Results Reference
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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.
Results Reference
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Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy

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