Skip to main content
OpenTrials
Completed

NCT Number: NCT05247320

Prospective Evaluation Analysis and Kinetics Registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 years and older
  • Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician
  • IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy
  • Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures

Exclusion criteria

  • Study materials not available in the subject's preferred language.
  • Patients undergoing treatment for active concomitant ventricular arrhythmias
  • 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)
  • Patients who were previously intolerant to antiarrhythmic class III therapy
  • Patients missing key data elements in their electronic health record (for retrospective subjects only).

Treatment and study plan

Sotalol Injection

Drug

Standard of care IV sotalol infusion for atrial arrhythmias

Primary outcomes

  1. Number of participants completing IV sotalol loading for atrial arrhythmias

    Time frame: 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 outcomes

  1. Number of participants with symptomatic/actionable bradycardia.

    Time frame: 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.

  2. Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).

    Time frame: 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.

  3. Number of participants with recurrent AT/AF +/- RVR.

    Time frame: 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.

  4. Number of participants with any ventricular arrhythmia (sustained or non-sustained.

    Time frame: 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.

  5. Number of participants with Sudden Cardiac Death (SCD) (including aborted).

    Time frame: 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.

  6. Number of participants with Hypotension Symptomatic or <=90/50.

    Time frame: 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.

  7. Number of participants with unplanned hospitalization prolongation.

    Time frame: 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.

  8. Number of participants with unplanned rehospitalization.

    Time frame: 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.

  9. Number of participants with death.

    Time frame: 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 outcomes

  1. Sotalol levels measured at 0-30 minutes before IV dose.

    Time frame: 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.

  2. Sotalol levels measured at 0-5 minutes after end of IV infusion.

    Time frame: 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.

  3. Sotalol levels measured at 3 hours ± 5 minutes after end of IV infusion.

    Time frame: 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.

  4. Sotalol levels measured at 0-30 minutes before first enteral dose.

    Time frame: 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.

  5. Sotalol levels measured at 2-4 hours after second enteral dose.

    Time frame: 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.

  6. Sotalol levels measured at 2-4 hours after first enteral dose.

    Time frame: 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.

  7. Number of participants on outpatient, mobile ECG with Bradycardia <= 40 bpm.

    Time frame: 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.

  8. Number of participants on outpatient, mobile ECG with recurrent AT/AF +/- RVR.

    Time frame: 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.

  9. Number of participants on outpatient, mobile ECG with QTc prolongation >500 ms (or 550 ms for underlying BBB).

    Time frame: 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.

  10. Number of participants on outpatient, mobile ECG with any ventricular arrhythmia (sustained or non-sustained).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • AltaThera Pharmaceuticals, LLC

Registry information

Official study title

Prospective Evaluation Analysis and Kinetics of IV Sotalol

Acronym: PEAKS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.