Prospective Evaluation Analysis and Kinetics Registry

Completed

• Conditions: Atrial Arrhythmia
• Interventions: Drug: Sotalol Injection

• Registration Number: NCT05247320
• Lead Sponsor: University of Utah

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study Start: 2022-02-04
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective	Sotalol Injection	-
Retrospective	Sotalol Injection	-

Primary Outcome Measures

Name	Time	Method
Number of participants completing IV sotalol loading for atrial arrhythmias	Enrollment of patient until 7 days following discharge	To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of Sotalol.

Secondary Outcome Measures

Name	Time	Method
Number of participants with symptomatic/actionable bradycardia.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with Sudden Cardiac Death (SCD) (including aborted).	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with unplanned rehospitalization.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with any ventricular arrhythmia (sustained or non-sustained.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with Hypotension Symptomatic or <=90/50.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with unplanned hospitalization prolongation.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with recurrent AT/AF +/- RVR.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Number of participants with death.	Infusion IV Sotalol out to 3 months.	To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States