Status:
COMPLETED
Prospective Evaluation Analysis and Kinetics Registry
Lead Sponsor:
University of Utah
Collaborating Sponsors:
AltaThera Pharmaceuticals, LLC
Conditions:
Atrial Arrhythmia
Eligibility:
All Genders
18-100 years
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, elec...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT05247320
Start Date
February 4 2022
End Date
August 30 2023
Last Update
September 26 2023
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112