Arrhythmias, Cardiac, Atrial Fibrillation
Conditions
Keywords
Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation
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.
Interventions
DRUGIntravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation
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.
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Munson Medical Center
Kansas City Heart Rhythm Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed