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

Atrial Fibrillation Clinical Trial

— DASH-AF  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04473807
• Other study ID #: KCHRF-DASH-AF-0002
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2, 2021
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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%

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Drug:
• Intravenous 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.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Munson Medical Center, Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Epub 2007 May 3. — View Citation

HIGHLIGHTS OF PRESCRIBING INFORMATION: Sotalol hydrochloride injection for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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