Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AltaThera Pharmaceuticals, LLC | UNKNOWN |
Not provided
Not provided
Not provided
In a cohort of patients electively treated for atrial arrhythmia with IV sotalol (initiation or dose escalation), this study will describe patient characteristics, short-term safety and efficacy, electrocardiographic monitoring, and PK and PD parameters (in a subset) associated with IV dosing approach.
Antiarrhythmic drug therapy plays a vital role in the achievement of rhythm control in patients with atrial arrhythmias. Class III antiarrhythmic drugs are frequently used in these patients. However, these drugs are associated with a nontrivial risk of QT interval prolongation and associated risk of life-threatening ventricular arrhythmias. In this setting, initiation and dose titration of these drugs is often performed on an inpatient basis for the first five oral doses, typically requiring hospitalization for two days or longer.
The availability of sotalol in intravenous (IV) form, recently approved for initiation or dose increase among patients with atrial arrhythmias, affords an opportunity to shorten hospitalization for these patients. This approach was approved based on translational science research that used computer-based simulation modeling to predict sotalol concentrations. There remain knowledge gaps regarding the use of IV sotalol in these patients, specifically around real-world outcomes, as well as pharmacodynamic and pharmacokinetic profiles in patients. The purpose of this registry is to collect data among patients and centers using IV sotalol loading for initiation or dose titration in the treatment of atrial arrhythmias, in order to fill the above knowledge gaps.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective |
| ||
| Retrospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotalol Injection | Drug | Standard of care IV sotalol infusion for atrial arrhythmias |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants completing IV sotalol loading for atrial arrhythmias | To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of Sotalol. | Enrollment of patient until 7 days following discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with symptomatic/actionable bradycardia. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB). |
| Measure | Description | Time Frame |
|---|---|---|
| Sotalol levels measured at 0-30 minutes before IV dose. | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. | 0 - 30 min before IV dose |
| Sotalol levels measured at 0-5 minutes after end of IV infusion. |
Inclusion Criteria:
Exclusion Criteria:
Study materials not available in the subject's preferred language.
Patients undergoing treatment for active concomitant ventricular arrhythmias
Standard exclusions for elective sotalol use (at the time of initiation):
Patients who were previously intolerant to antiarrhythmic class III therapy
Patients missing key data elements in their electronic health record (for retrospective subjects only).
Not provided
Not provided
This registry study will enroll adult patients 18 years and older electively treated for atrial arrhythmia with standard of care IV sotalol (initiation or dose escalation). During their elective hospitalization the patient is not planned to receive any other intervention. The registry allows retrospective and prospective enrollment. Patients will be excluded if they are undergoing treatment for active concomitant ventricular arrhythmias, intolerant to class III antiarrhythmic therapy, not meeting standard criteria to receive elective IV sotalol, or if key data elements not available (retrospective enrolled patients only). Approximately 150 patients will be enrolled and for about 20 patients PK/PD data will be collected.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin A. Steinberg, MD, MHS | University of Utah | Principal Investigator |
| Jonathan Pinccini, MD | Duke University | Principal Investigator |
| Suneet Mittal, MD | Valley Health | Principal Investigator |
| Parash Pokharel, MD | Geisinger Health | Principal Investigator |
| Thomas F Deering, MD | Piedmont Heart Institute | Principal Investigator |
| Robert Kennedy, MD | Munson Medical Center | Principal Investigator |
| Michael West, MD | Presbyterian Healthcare Services | Principal Investigator |
| Sergio Cossu, MD | Lehigh Valley Health Network | Principal Investigator |
| Nishant Verma, MD | Northwestern University | Principal Investigator |
| Jonathan Silver, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32849964 | Background | Somberg JC, Vinks AA, Dong M, Molnar J. Model-Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion. Cardiol Res. 2020 Oct;11(5):294-304. doi: 10.14740/cr1143. Epub 2020 Aug 7. | |
| 29853342 | Background | Samanta R, Thiagalingam A, Turner C, Lakkireddy DJ, Kovoor P. The Use of Intravenous Sotalol in Cardiac Arrhythmias. Heart Lung Circ. 2018 Nov;27(11):1318-1326. doi: 10.1016/j.hlc.2018.03.017. Epub 2018 Mar 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. |
| Infusion IV Sotalol out to 3 months. |
| Number of participants with recurrent AT/AF +/- RVR. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with any ventricular arrhythmia (sustained or non-sustained. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with Sudden Cardiac Death (SCD) (including aborted). | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with Hypotension Symptomatic or <=90/50. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with unplanned hospitalization prolongation. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with unplanned rehospitalization. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
| Number of participants with death. | To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice. | Infusion IV Sotalol out to 3 months. |
To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. |
| 0-5 minutes after end of IV infusion. |
| Sotalol levels measured at 3 hours ± 5 minutes after end of IV infusion. | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. | 3 hours ± 5 minutes after end of IV infusion. |
| Sotalol levels measured at 0-30 minutes before first enteral dose. | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. | 0-30 minutes before first enteral dose. |
| Sotalol levels measured at 2-4 hours after second enteral dose. | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. | 2-4 hours after second enteral dose. |
| Sotalol levels measured at 2-4 hours after first enteral dose. | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. | 2-4 hours after first enteral dose. |
| Number of participants on outpatient, mobile ECG with Bradycardia <= 40 bpm. | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. | Enrollment until 7 days following discharge |
| Number of participants on outpatient, mobile ECG with recurrent AT/AF +/- RVR. | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. | Enrollment until 7 days following discharge |
| Number of participants on outpatient, mobile ECG with QTc prolongation >500 ms (or 550 ms for underlying BBB). | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. | Enrollment until 7 days following discharge |
| Number of participants on outpatient, mobile ECG with any ventricular arrhythmia (sustained or non-sustained). | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. | Enrollment until 7 days following discharge |
| Lahey Hospital & Medical Center |
| Principal Investigator |
| Abhishek Deshmukh, MD | Mayo Clinic | Principal Investigator |
| 20693799 | Background | Somberg JC, Preston RA, Ranade V, Molnar J. QT prolongation and serum sotalol concentration are highly correlated following intravenous and oral sotalol. Cardiology. 2010;116(3):219-25. doi: 10.1159/000316050. Epub 2010 Aug 7. |
| 31341782 | Background | Von Bergen NH, Beshish AG, Maginot KR. Outpatient intravenous sotalol load to replace 3-day admission oral sotalol load. HeartRhythm Case Rep. 2019 Apr 24;5(7):382-383. doi: 10.1016/j.hrcr.2019.04.005. eCollection 2019 Jul. No abstract available. |
| 32327077 | Background | Etheridge SP, Asaki SY. An Exciting New Tool in the Electrophysiologist's Toolbox, Intravenous Sotalol: Faster, Safer, Better? JACC Clin Electrophysiol. 2020 Apr;6(4):433-435. doi: 10.1016/j.jacep.2019.12.016. No abstract available. |
| 40321743 | Derived | Steinberg BA, Mittal S, Holubkov R, Groh CA, Kennedy R, Pokharel P, Perez M, Savona SJ, Verma N, Watt K, Piccini JP, Bunch TJ, Deering TF. Correlation between mobile and 12-lead ECG among patients loading with intravenous sotalol: A PEAKS substudy. Heart Rhythm O2. 2025 Feb 11;6(4):499-508. doi: 10.1016/j.hroo.2025.01.018. eCollection 2025 Apr. |
| 40205819 | Derived | Steinberg BA, Holubkov R, Bunch TJ, Deering TF, Groh CA, Kennedy R, Perez M, Piccini JP, Pokharel P, Savona SJ, Verma N, Watt K, Mittal S. Sotalol Dosing and Outcomes Among Patients Undergoing Intravenous Loading for Atrial Arrhythmias-A PEAKS Registry Substudy. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1352-1358. doi: 10.1111/jce.16677. Epub 2025 Apr 9. |
| D000588 |
| Amines |