Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
NCT ID: NCT04473807
Last Updated: 2022-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2021-01-02
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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DASH-AF
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.
Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
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.
Interventions
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Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%
18 Years
85 Years
ALL
No
Sponsors
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Texas Cardiac Arrhythmia Research Foundation
OTHER
Munson Medical Center
OTHER
Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Research Foundation
Locations
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Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
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.
Lakkireddy D, Ahmed A, Atkins D, Bawa D, Garg J, Bush J, Charate R, Bommana S, Pothineni NVK, Kabra R, Darden D, Koreber S, Tummala R, Vasamreddy C, Park P, Mohanty S, Gopinathannair R, Seo BW, Natale A, Kennedy R. Feasibility and Safety of Intravenous Sotalol Loading in Adult Patients With Atrial Fibrillation (DASH-AF). JACC Clin Electrophysiol. 2023 Apr;9(4):555-564. doi: 10.1016/j.jacep.2022.11.026. Epub 2023 Feb 22.
Other Identifiers
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KCHRF-DASH-AF-0002
Identifier Type: -
Identifier Source: org_study_id
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