University of Utah
Salt Lake City, Utah, 84112, United States
NCT Number: NCT05247320
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.
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Notify Me18 year–100 year
All sexes
Observational
Salt Lake City, Utah, 84112, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care IV sotalol infusion 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
University of Utah
Other
Prospective Evaluation Analysis and Kinetics of IV Sotalol
Acronym: PEAKS
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.
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