Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Atrial Arrhythmia

Treatments: Drug: Sotalol Injection

Study type: Observational

Funder types: Other

Identifiers

NCT05247320

00147440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

167 participants in 2 patient groups

Prospective

Treatment:

Drug: Sotalol Injection

Retrospective

Treatment:

Drug: Sotalol Injection