Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy

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.

Timeline

Start

2021-01-02

Primary completion

2022-04

Completion

2022-06

Publications

• Background 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.
• Background 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.
• Background HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
• Background 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.

Drugs

Indications