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Trial record 1 of 1 for:    NCT05247320
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Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

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ClinicalTrials.gov Identifier: NCT05247320
Recruitment Status : Enrolling by invitation
First Posted : February 18, 2022
Last Update Posted : August 30, 2022
Sponsor:
Collaborator:
AltaThera Pharmaceuticals, LLC
Information provided by (Responsible Party):
Benjamin A. Steinberg, University of Utah

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.

Condition or disease Intervention/treatment
Atrial Arrhythmia Drug: Sotalol Injection

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prospective Evaluation Analysis and Kinetics of IV Sotalol
Actual Study Start Date : February 4, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Prospective Drug: Sotalol Injection
Standard of care IV sotalol infusion for atrial arrhythmias

Retrospective Drug: Sotalol Injection
Standard of care IV sotalol infusion for atrial arrhythmias




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants with symptomatic/actionable bradycardia. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  2. Number of participants with QTc prolongation >500 ms (or 550 ms for underlying BBB). [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  3. Number of participants with recurrent AT/AF +/- RVR. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  4. Number of participants with any ventricular arrhythmia (sustained or non-sustained. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  5. Number of participants with Sudden Cardiac Death (SCD) (including aborted). [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  6. Number of participants with Hypotension Symptomatic or <=90/50. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  7. Number of participants with unplanned hospitalization prolongation. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  8. Number of participants with unplanned rehospitalization. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.

  9. Number of participants with death. [ Time Frame: Infusion IV Sotalol out to 3 months. ]
    To describe the short-term safety and efficacy outcomes among patients receiving IV Sotalol for atrial arrhythmias in clinical practice.


Other Outcome Measures:
  1. Sotalol levels measured at 0-30 minutes before IV dose. [ Time Frame: 0 - 30 min before IV dose ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  2. Sotalol levels measured at 0-5 minutes after end of IV infusion. [ Time Frame: 0-5 minutes after end of IV infusion. ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  3. Sotalol levels measured at 3 hours ± 5 minutes after end of IV infusion. [ Time Frame: 3 hours ± 5 minutes after end of IV infusion. ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  4. Sotalol levels measured at 0-30 minutes before first enteral dose. [ Time Frame: 0-30 minutes before first enteral dose. ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  5. Sotalol levels measured at 2-4 hours after second enteral dose. [ Time Frame: 2-4 hours after second enteral dose. ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  6. Sotalol levels measured at 2-4 hours after first enteral dose. [ Time Frame: 2-4 hours after first enteral dose. ]
    To describe the pharmacokinetics (PK) of IV Sotalol in vivo and compare it to the profiles predicted through modeling.

  7. Number of participants on outpatient, mobile ECG with Bradycardia <= 40 bpm. [ Time Frame: Enrollment until 7 days following discharge ]
    Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients.

  8. Number of participants on outpatient, mobile ECG with recurrent AT/AF +/- RVR. [ Time Frame: Enrollment until 7 days following discharge ]
    Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients.

  9. Number of participants on outpatient, mobile ECG with QTc prolongation >500 ms (or 550 ms for underlying BBB). [ Time Frame: Enrollment until 7 days following discharge ]
    Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients.

  10. Number of participants on outpatient, mobile ECG with any ventricular arrhythmia (sustained or non-sustained). [ Time Frame: Enrollment until 7 days following discharge ]
    Assess the use of mobile ECG to detect clinically-significant arrhythmia and changes to heart rate and QTc among these patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05247320


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
AltaThera Pharmaceuticals, LLC
Investigators
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Principal Investigator: 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
Principal Investigator: Jonathan Silver, MD Lahey Hospital & Medical Center
Principal Investigator: Abhishek Deshmukh, MD Mayo Clinic
Publications:
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Responsible Party: Benjamin A. Steinberg, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT05247320    
Other Study ID Numbers: 00147440
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Benjamin A. Steinberg, University of Utah:
Atrial Arrhythmia
Sotalol
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sotalol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents