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

NCT04473807 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: KCHRF-DASH-AF-0002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Keywords

Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DASH-AF

OTHER

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

Interventions

Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation DRUG

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.

Also known as: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy

DASH-AF

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Texas Cardiac Arrhythmia Research Foundation: collaborator
• Munson Medical Center: collaborator

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 15193827 BACKGROUND

• 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.

  PMID: 17488270 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• Lakkireddy D, Ahmed A, Atkins D, Bawa D, Garg J, Bush J, Charate R, Bommana S, Pothineni NVK, Kabra R, Darden D, Koreber S, Tummala R, Vasamreddy C, Park P, Mohanty S, Gopinathannair R, Seo BW, Natale A, Kennedy R. Feasibility and Safety of Intravenous Sotalol Loading in Adult Patients With Atrial Fibrillation (DASH-AF). JACC Clin Electrophysiol. 2023 Apr;9(4):555-564. doi: 10.1016/j.jacep.2022.11.026. Epub 2023 Feb 22.

  PMID: 37014289 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: January 2, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)