Prospective Evaluation Analysis and Kinetics Registry

Atrial Arrhythmia Clinical Trial

— PEAKS  

Official title:

Prospective Evaluation Analysis and Kinetics of IV Sotalol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247320
• Other study ID #: 00147440
• Status: Completed
• Start date: February 4, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adults age 18 years and older

2. Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician

3. IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy

4. Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures

Exclusion Criteria:

1. Study materials not available in the subject's preferred language.

2. Patients undergoing treatment for active concomitant ventricular arrhythmias

3. Standard exclusions for elective sotalol use (at the time of initiation):

• Heart rate < 40 bpm or 2nd/3rd degree AV block without pacemaker
• QTc = 450 in absence of bundle branch block (= 500 in the presence of a bundle branch block)
• Severe left ventricular hypertrophy (thickness >1.5 cm)

4. Patients who were previously intolerant to antiarrhythmic class III therapy

5. Patients missing key data elements in their electronic health record (for retrospective subjects only).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia

Intervention

Drug:
• Sotalol Injection
Standard of care IV sotalol infusion for atrial arrhythmias

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	AltaThera Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Sotalol levels measured at 0-5 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.	0-5 minutes after end of IV infusion.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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.
Secondary	Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.