Prospective Evaluation Analysis and Kinetics of IV Sotalol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Number of participants completing IV sotalol loading for atrial arrhythmias
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Prospective
干预措施: Sotalol Injection (Drug)
Retrospective
干预措施: Sotalol Injection (Drug)
结局指标
主要结局
Number of participants completing IV sotalol loading for atrial arrhythmias
时间窗: 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.
次要结局
- Number of participants with symptomatic/actionable bradycardia.(Infusion IV Sotalol out to 3 months.)
- Number of participants with Sudden Cardiac Death (SCD) (including aborted).(Infusion IV Sotalol out to 3 months.)
- Number of participants with unplanned rehospitalization.(Infusion IV Sotalol out to 3 months.)
- Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).(Infusion IV Sotalol out to 3 months.)
- Number of participants with any ventricular arrhythmia (sustained or non-sustained.(Infusion IV Sotalol out to 3 months.)
- Number of participants with Hypotension Symptomatic or <=90/50.(Infusion IV Sotalol out to 3 months.)
- Number of participants with unplanned hospitalization prolongation.(Infusion IV Sotalol out to 3 months.)
- Number of participants with recurrent AT/AF +/- RVR.(Infusion IV Sotalol out to 3 months.)
- Number of participants with death.(Infusion IV Sotalol out to 3 months.)
研究者
Benjamin A. Steinberg
Associate Professor
University of Utah