NCT05247320

Prospective Evaluation Analysis and Kinetics Registry

Prospective Evaluation Analysis and Kinetics of IV Sotalol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Arrhythmia

Interventions

Type	Name	Description
DRUG	Sotalol Injection	Standard of care IV sotalol infusion for atrial arrhythmias

Timeline

• Start date: 2022-02-04
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-02-18
• Last updated: 2023-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study