Clinical trial NCT04473807: Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy
Official title: Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation (DASH-AF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Keywords: Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Texas Cardiac Arrhythmia Research Foundation
name: Munson Medical Center
First posted: 2020-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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%

Primary outcomes:
measure: intravenous loading regimen followed by q12h oral sotalol administration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Research Foundation
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boriani G, Valzania C, Biffi M, Corazza I, Camanini C, Martignani C, Bacchi L, Zannoli R, Branzi A. Increase in QT/QTc dispersion after low energy cardioversion of chronic persistent atrial fibrillation. Int J Cardiol. 2004 Jun;95(2-3):245-50. doi: 10.1016/j.ijcard.2003.05.022.
citation: Darbar D, Hardin B, Harris P, Roden DM. A rate-independent method of assessing QT-RR slope following conversion of atrial fibrillation. J Cardiovasc Electrophysiol. 2007 Jun;18(6):636-41. doi: 10.1111/j.1540-8167.2007.00817.x. Epub 2007 May 3.
citation: HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
citation: Woosley RL, Heise CW, Tate J, Woosley D, Romero KA, Gallo T. QTdrugs List. https://crediblemeds.org/index.php/?cID=328. Accessed August 28, 2019.