Prospective Evaluation Analysis and Kinetics Registry

NCT ID: NCT05247320

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2023-08-30

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.

Detailed Description

Antiarrhythmic drug therapy plays a vital role in the achievement of rhythm control in patients with atrial arrhythmias. Class III antiarrhythmic drugs are frequently used in these patients. However, these drugs are associated with a nontrivial risk of QT interval prolongation and associated risk of life-threatening ventricular arrhythmias. In this setting, initiation and dose titration of these drugs is often performed on an inpatient basis for the first five oral doses, typically requiring hospitalization for two days or longer.

The availability of sotalol in intravenous (IV) form, recently approved for initiation or dose increase among patients with atrial arrhythmias, affords an opportunity to shorten hospitalization for these patients. This approach was approved based on translational science research that used computer-based simulation modeling to predict sotalol concentrations. There remain knowledge gaps regarding the use of IV sotalol in these patients, specifically around real-world outcomes, as well as pharmacodynamic and pharmacokinetic profiles in patients. The purpose of this registry is to collect data among patients and centers using IV sotalol loading for initiation or dose titration in the treatment of atrial arrhythmias, in order to fill the above knowledge gaps.

Conditions

Atrial Arrhythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prospective

Sotalol Injection

Intervention Type: DRUG

Standard of care IV sotalol infusion for atrial arrhythmias

Retrospective

Sotalol Injection

Intervention Type: DRUG

Standard of care IV sotalol infusion for atrial arrhythmias

Interventions

Sotalol Injection

Standard of care IV sotalol infusion for atrial arrhythmias

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults age 18 years and older

2. Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician

3. IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy

4. Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures

Exclusion Criteria

1. Study materials not available in the subject's preferred language.

2. Patients undergoing treatment for active concomitant ventricular arrhythmias

3. Standard exclusions for elective sotalol use (at the time of initiation):

• 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)

4. Patients who were previously intolerant to antiarrhythmic class III therapy

5. Patients missing key data elements in their electronic health record (for retrospective subjects only).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AltaThera Pharmaceuticals, LLC

UNKNOWN

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Benjamin A. Steinberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin A. Steinberg, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Jonathan Pinccini, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Suneet Mittal, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Health

Parash Pokharel, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Health

Thomas F Deering, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Robert Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

Munson Medical Center

Michael West, MD

Role: PRINCIPAL_INVESTIGATOR

Presbyterian Healthcare Services

Sergio Cossu, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Health Network

Nishant Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Jonathan Silver, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Abhishek Deshmukh, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32849964 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29853342 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20693799 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31341782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32327077 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40321743 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40205819 (View on PubMed)

Other Identifiers

00147440

Identifier Type: -

Identifier Source: org_study_id