Status:
UNKNOWN
Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
Lead Sponsor:
Kansas City Heart Rhythm Research Foundation
Collaborating Sponsors:
Texas Cardiac Arrhythmia Research Foundation
Munson Medical Center
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and feasibility of the IV loading strategy in patients who are selected to receive sotalol.
Detailed Description
This is an open-label single arm study investigating the safety and feasibility of an intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed Consent will be obta...
Eligibility Criteria
Inclusion
- Male and female between 18 - 85 years old
- Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy
- History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy
- Creatinine clearance ≥60 mL/min
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Exclusion
- Baseline bradycardia (\<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs
- Sick sinus syndrome, unless a functioning pacemaker is present.
- Any known sensitivities to beta-blockers
- Uncontrolled heart failure
- Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block
- Recent (within 7 days) surgical or catheter ablation procedure
- Severe electrolyte abnormalities (including serum K\<3.5)
- Known use of other QTc prolonging drugs (See Appendix A)
- Recent (within 7 days) sotalol use
- Baseline QTc \>450 ms
- Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant
- History of Torsade de Pointes (TdP)
- Pregnancy or breastfeeding
- Left ventricular ejection fraction (LVEF) less than 35%
Key Trial Info
Start Date :
January 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04473807
Start Date
January 2 2021
End Date
June 1 2022
Last Update
January 14 2022
Active Locations (1)
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1
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66211