Atrial Arrhythmia
Conditions
Keywords
Atrial Arrhythmia, Sotalol
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.
Interventions
DRUGSotalol Injection
Standard of care IV sotalol infusion for atrial arrhythmias
Sponsors
AltaThera Pharmaceuticals, LLC
University of Utah
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sotalol levels measured at 0-30 minutes before IV dose. | 0 - 30 min before IV dose | To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling. |
| Sotalol levels measured at 0-5 minutes after end of IV infusion. | 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. |
| Sotalol levels measured at 3 hours ± 5 minutes after end of IV infusion. | 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. |
| Sotalol levels measured at 0-30 minutes before first enteral dose. | 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. |
| Sotalol levels measured at 2-4 hours after second enteral dose. | 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. |
| Sotalol levels measured at 2-4 hours after first enteral dose. | 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. |
| Number of participants on outpatient, mobile ECG with Bradycardia <= 40 bpm. | Enrollment until 7 days following discharge | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. |
| Number of participants on outpatient, mobile ECG with recurrent AT/AF +/- RVR. | Enrollment until 7 days following discharge | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. |
| Number of participants on outpatient, mobile ECG with QTc prolongation >500 ms (or 550 ms for underlying BBB). | Enrollment until 7 days following discharge | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. |
| Number of participants on outpatient, mobile ECG with any ventricular arrhythmia (sustained or non-sustained). | Enrollment until 7 days following discharge | Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients. |
Countries
United States
Outcome results
None listed