Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansas City Heart Rhythm Research Foundation
• Treatments: 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%