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

Phase 4

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation
• Interventions: Drug: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation

• Registration Number: NCT04473807
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

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 obtained from all patients prior to enrollment in the study. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol loading.

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2021-01-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DASH-AF	Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation	Patients with history of highly symptomatic persistent or paroxysmal AF who are scheduled for sotalol therapy once in sinus rhythm will be enrolled in this study.

Primary Outcome Measures

Name	Time	Method
intravenous loading regimen followed by q12h oral sotalol administration	3 months	The hypothesis to be tested is that the intravenous loading regimen followed by q12h oral sotalol administration will result in sotalol concentration and QTc peaks on day 1 (IV to oral loading) which are comparable to the steady-state and maximum QTc seen on Day 3 (steady-state).

Trial Locations

Locations (1)

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States