Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

Overview

About this study

The primary objectives of the study are as follows:

To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of sotalol;
To describe the short-term safety and efficacy outcomes among patients receiving IV sotalol for atrial arrhythmias in clinical practice;
To describe the pharmacokinetics (PK) and pharmacodynamics (PD) associated with IV sotalol loading;
To assess feasibility of mobile ECG technology for monitoring among patients undergoing antiarrhythmic drug treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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 .

Exclusion Criteria:

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).

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Abhishek Deshmukh, M.B.B.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Abhishek Deshmukh, M.B.B.S.

Closed for enrollment

More information

Publications

Sotalol is often employed to prevent recurrence of symptomatic atrial flutter/atrial fibrillation. Because sotalol can prolong the QT interval excessively causing ventricular arrhythmias, a 3-day in-hospital loading or dose escalation period is mandated with oral administration in the product label for patient safety. In patients with normal renal function, 3 days (five oral doses) are required to obtain steady state maximum sotalol concentration, which results in maximum QT prolongation. The aim of this study is to develop an intravenous to oral loading regime for sotalol therapy that reduces the 3-day in-hospital initiation or dose escalation with oral administration to 1 day without compromising patient safety. Read More on PubMed
Sotalol is a non-selective beta-adrenergic blocking agent without intrinsic sympathomimetic activity. It has the additional unique property of producing pronounced prolongation of the cardiac action potential duration. Sotalol therapy has been indicated for the management of supraventricular arrhythmias, refractory life threatening ventricular arrhythmias and atrial fibrillation/flutter. Until recently, sotalol was only available in the oral form, however, it was approved for intravenous administration by the US Food & Drug Administration (FDA). The current recommendations are for sotalol 75-150mg to be administered intravenously over 5hours. This rate of administration does not reflect the majority of the research that has been performed with regards to intravenous sotalol. Also, the safety of intravenous bolus dosing of 100mg over 1 and 5minutes has previously been demonstrated. The antiarrhythmic action of sotalol depends on its ability to prolong refractoriness in the nodal and extra nodal tissue. Hence, by giving a lower dose over a long duration, patients may not necessarily benefit from its anti-arrhythmic potential. The purpose of this article is to review the research that has been conducted with regards to dosage and safety of intravenous sotalol, its electrophysiological effects and finally the spectrum of arrhythmias in which it has been used to date. Read More on PubMed
The aim of this study was to evaluate the correlation between QT interval (QT) and serum sotalol concentration following a single low dose of oral and intravenous sotalol. Read More on PubMed

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