Prospective Evaluation Analysis and Kinetics Registry

NCT05247320 | Completed FDA Drug

• 1 other identifier: 00147440
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

In a cohort of patients electively treated for atrial arrhythmia with IV sotalol (initiation or dose escalation), this study will describe patient characteristics, short-term safety and efficacy, electrocardiographic monitoring, and PK and PD parameters (in a subset) associated with IV dosing approach.

Conditions

Atrial Arrhythmia

Keywords

Atrial Arrhythmia; Sotalol

Outcome Measures

Primary Outcomes (1)

• Number of participants completing IV sotalol loading for atrial arrhythmias

  To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of Sotalol.

  Enrollment of patient until 7 days following discharge

Secondary Outcomes (9)

• Number of participants with symptomatic/actionable bradycardia.

  Infusion IV Sotalol out to 3 months.

• Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).

  Infusion IV Sotalol out to 3 months.

• Number of participants with recurrent AT/AF +/- RVR.

  Infusion IV Sotalol out to 3 months.

• Number of participants with any ventricular arrhythmia (sustained or non-sustained.

  Infusion IV Sotalol out to 3 months.

• Number of participants with Sudden Cardiac Death (SCD) (including aborted).

  Infusion IV Sotalol out to 3 months.

Other Outcomes (10)

• Sotalol levels measured at 0-30 minutes before IV dose.

  0 - 30 min before IV dose

• Sotalol levels measured at 0-5 minutes after end of IV infusion.

  0-5 minutes after end of IV infusion.

• Sotalol levels measured at 3 hours ± 5 minutes after end of IV infusion.

  3 hours ± 5 minutes after end of IV infusion.

Study Arms (2)

Prospective

Drug: Sotalol Injection

Retrospective

Drug: Sotalol Injection

Interventions

Sotalol Injection DRUG

Standard of care IV sotalol infusion for atrial arrhythmias

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This registry study will enroll adult patients 18 years and older electively treated for atrial arrhythmia with standard of care IV sotalol (initiation or dose escalation). During their elective hospitalization the patient is not planned to receive any other intervention. The registry allows retrospective and prospective enrollment. Patients will be excluded if they are undergoing treatment for active concomitant ventricular arrhythmias, intolerant to class III antiarrhythmic therapy, not meeting standard criteria to receive elective IV sotalol, or if key data elements not available (retrospective enrolled patients only). Approximately 150 patients will be enrolled and for about 20 patients PK/PD data will be collected.

You may qualify if:

• Adults age 18 years and older
• Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician
• IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy
• Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures

You may not qualify if:

• Study materials not available in the subject's preferred language.
• Patients undergoing treatment for active concomitant ventricular arrhythmias
• Heart rate \< 40 bpm or 2nd/3rd degree AV block without pacemaker
• QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block)
• Severe left ventricular hypertrophy (thickness \>1.5 cm)
• Patients who were previously intolerant to antiarrhythmic class III therapy
• Patients missing key data elements in their electronic health record (for retrospective subjects only).

Sponsors & Collaborators

• University of Utah: lead
• AltaThera Pharmaceuticals, LLC: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (7)

• Somberg JC, Vinks AA, Dong M, Molnar J. Model-Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion. Cardiol Res. 2020 Oct;11(5):294-304. doi: 10.14740/cr1143. Epub 2020 Aug 7.

  PMID: 32849964 BACKGROUND

• Samanta R, Thiagalingam A, Turner C, Lakkireddy DJ, Kovoor P. The Use of Intravenous Sotalol in Cardiac Arrhythmias. Heart Lung Circ. 2018 Nov;27(11):1318-1326. doi: 10.1016/j.hlc.2018.03.017. Epub 2018 Mar 29.

  PMID: 29853342 BACKGROUND

• Somberg JC, Preston RA, Ranade V, Molnar J. QT prolongation and serum sotalol concentration are highly correlated following intravenous and oral sotalol. Cardiology. 2010;116(3):219-25. doi: 10.1159/000316050. Epub 2010 Aug 7.

  PMID: 20693799 BACKGROUND

• Von Bergen NH, Beshish AG, Maginot KR. Outpatient intravenous sotalol load to replace 3-day admission oral sotalol load. HeartRhythm Case Rep. 2019 Apr 24;5(7):382-383. doi: 10.1016/j.hrcr.2019.04.005. eCollection 2019 Jul. No abstract available.

  PMID: 31341782 BACKGROUND

• Etheridge SP, Asaki SY. An Exciting New Tool in the Electrophysiologist's Toolbox, Intravenous Sotalol: Faster, Safer, Better? JACC Clin Electrophysiol. 2020 Apr;6(4):433-435. doi: 10.1016/j.jacep.2019.12.016. No abstract available.

  PMID: 32327077 BACKGROUND

• Steinberg BA, Mittal S, Holubkov R, Groh CA, Kennedy R, Pokharel P, Perez M, Savona SJ, Verma N, Watt K, Piccini JP, Bunch TJ, Deering TF. Correlation between mobile and 12-lead ECG among patients loading with intravenous sotalol: A PEAKS substudy. Heart Rhythm O2. 2025 Feb 11;6(4):499-508. doi: 10.1016/j.hroo.2025.01.018. eCollection 2025 Apr.

  PMID: 40321743 DERIVED

• Steinberg BA, Holubkov R, Bunch TJ, Deering TF, Groh CA, Kennedy R, Perez M, Piccini JP, Pokharel P, Savona SJ, Verma N, Watt K, Mittal S. Sotalol Dosing and Outcomes Among Patients Undergoing Intravenous Loading for Atrial Arrhythmias-A PEAKS Registry Substudy. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1352-1358. doi: 10.1111/jce.16677. Epub 2025 Apr 9.

  PMID: 40205819 DERIVED

MeSH Terms

Interventions

Sotalol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Benjamin A. Steinberg, MD, MHS

  University of Utah

  PRINCIPAL INVESTIGATOR

• Jonathan Pinccini, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Suneet Mittal, MD

  Valley Health

  PRINCIPAL INVESTIGATOR

• Parash Pokharel, MD

  Geisinger Health

  PRINCIPAL INVESTIGATOR

• Thomas F Deering, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Robert Kennedy, MD

  Munson Medical Center

  PRINCIPAL INVESTIGATOR

• Michael West, MD

  Presbyterian Healthcare Services

  PRINCIPAL INVESTIGATOR

• Sergio Cossu, MD

  Lehigh Valley Health Network

  PRINCIPAL INVESTIGATOR

• Nishant Verma, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jonathan Silver, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Abhishek Deshmukh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 18, 2022
• Study Start: February 4, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)