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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation (DASH-AF)

Conditions
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Arrhythmias, Cardiac, Atrial Fibrillation

Intervention / Treatment
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* Drug: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DASH-AF<br>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. | Drug: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation<br>* The hypothesis to be tested is that the intravenous loading regimen followed by oral sotalol administration 4 hours after the conclusion of the IV infusion (every 12 hours thereafter) will result in sotalol peak concentrations at the end of IV loading dose (IV to oral loading) which are comparable to the steady state and maximum QTc seen on Day 3 after the last in-hospital oral dose.<br>* Other names: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravenous loading regimen followed by q12h oral sotalol administration | 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). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation