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

Status unconfirmed · Phase 4

Conditions studied: Arrhythmias, Cardiac, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04473807

Run by

Kansas City Heart Rhythm Research Foundation

People needed

80

Starts

2021-01-02

Expected to finish

2022-06-01

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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