Atrial ArrhythmiaPEAKSNCT05247320
Prospective Evaluation Analysis and Kinetics Registry
An observational study of Atrial Arrhythmia, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Arrhythmia
- What is being tested?
- Sotalol Injection
- Type of treatment
- Injection or infusion
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Study materials not available in the subject's preferred language.
- Patients undergoing treatment for active concomitant ventricular arrhythmias
- 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)
- Patients who were previously intolerant to antiarrhythmic class III therapy
- Patients missing key data elements in their electronic health record (for retrospective subjects only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation Analysis and Kinetics of IV Sotalol
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.
Read the 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
- Being tested
- Sotalol Injection
- Keywords
- Atrial Arrhythmia, Sotalol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sotalol InjectionDrug
Standard of care IV sotalol infusion for atrial arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Not described Receives: Drug: Sotalol Injection | |
| Retrospective | Not described Receives: Drug: Sotalol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment of patient until 7 days following discharge
Secondary outcomes (9)
Number of participants with symptomatic/actionable bradycardia.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with recurrent AT/AF +/- RVR.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with any ventricular arrhythmia (sustained or non-sustained.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with Sudden Cardiac Death (SCD) (including aborted).
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with Hypotension Symptomatic or <=90/50.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with unplanned hospitalization prolongation.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with unplanned rehospitalization.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Number of participants with death.
To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.
Measured: Infusion IV Sotalol out to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start4 Feb 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- AltaThera Pharmaceuticals, LLC
- Responsible party
- Principal investigator, Benjamin A. Steinberg, University of Utah
- Investigators
- Benjamin A. Steinberg, MD, MHS, Principal investigator, University of UtahJonathan Pinccini, MD, Principal investigator, Duke UniversitySuneet Mittal, MD, Principal investigator, Valley HealthParash Pokharel, MD, Principal investigator, Geisinger HealthThomas F Deering, MD, Principal investigator, Piedmont Heart InstituteRobert Kennedy, MD, Principal investigator, Munson Medical CenterMichael West, MD, Principal investigator, Presbyterian Healthcare ServicesSergio Cossu, MD, Principal investigator, Lehigh Valley Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247320
- Sponsor's protocol ID
- 00147440
- Acronym
- PEAKS
- Status last verified
- Sep 2023
- First submitted
- 7 Jan 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32849964Samanta 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.
PubMed 29853342Somberg 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.
PubMed 20693799Von 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.
PubMed 31341782Etheridge 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.
PubMed 32327077Steinberg 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.
PubMed 40321743Steinberg 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.
PubMed 40205819
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Analysis and Kinetics of IV Sotalol
- ClinicalTrials.gov ID
- NCT05247320
- Acronym / sponsor ID
- PEAKS / 00147440
- Conditions
- Atrial Arrhythmia
- Keywords
- Atrial Arrhythmia, Sotalol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- AltaThera Pharmaceuticals, LLC
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Drug: Sotalol Injection |
| Retrospective | – | Drug: Sotalol Injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Study materials not available in the subject's preferred language.
- Patients undergoing treatment for active concomitant ventricular arrhythmias
- Standard exclusions for elective sotalol use (at the time of initiation):
- Patients who were previously intolerant to antiarrhythmic class III therapy
- Patients missing key data elements in their electronic health record (for retrospective subjects only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sotalol InjectionStandard of care IV sotalol infusion for atrial arrhythmias | Drug | Prospective, Retrospective |
Primary outcome
Number of participants completing IV sotalol loading for atrial arrhythmias
Time frame: Enrollment of patient until 7 days following discharge
To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of Sotalol.
9 secondary outcomes
Number of participants with symptomatic/actionable bradycardia.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB).
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with recurrent AT/AF +/- RVR.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with any ventricular arrhythmia (sustained or non-sustained.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with Sudden Cardiac Death (SCD) (including aborted).
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with Hypotension Symptomatic or <=90/50.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with unplanned hospitalization prolongation.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with unplanned rehospitalization.
Time frame: Infusion IV Sotalol out to 3 months.
Number of participants with death.
Time frame: Infusion IV Sotalol out to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 32849964Somberg 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.
- Background: PubMed 29853342Samanta 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.
- Background: PubMed 20693799Somberg 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.
- Background: PubMed 31341782Von 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.
- Background: PubMed 32327077Etheridge 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.
- Derived from this study: PubMed 40321743Steinberg 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.
- Derived from this study: PubMed 40205819Steinberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin A. Steinberg, MD, MHS principal investigator
University of Utah
Jonathan Pinccini, MD principal investigator
Duke University
Suneet Mittal, MD principal investigator
Valley Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Arrhythmia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing IV sotalol loading for atrial arrhythmias (time frame: Enrollment of patient until 7 days following discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247320, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.