Overview
Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
Status:
Recruiting
Recruiting
Trial end date:
2021-09-30
2021-09-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kansas City Heart Rhythm Research FoundationTreatments:
Sotalol
Criteria
Inclusion Criteria:- 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 Criteria:
- 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%