Safety Assessment for Sotalol Protocol in Outpatient Unit (Sotalol)

July 7, 2022 updated by: Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital

Sotalol is an antiarrhythmic medication with proven effects for the suppression and prevention of supraventricular and ventricular arrhythmias. Due to its potential proarrhythmic effect, its introduction should be cautious, and several guidelines recommend starting the medication in hospital settings. However, patients at low risk for a proarrhythmic effect start the medication in outpatient units, despite the lack of clinical studies in the literature that demonstrate the safety of introducing the medication outside the hospital environment.

This research project aims to assess the safety introduction of sotalol in an outpatient unit basis. Our hypothesis is that outpatient introduction of sotalol is safe for low-risk patients and an electrocardiographic analysis after 2 hours of the first dose of medication is a predictor of electrocardiographic changes found after 72 hours.

In this research, serial electrocardiographic analysis with measurements of the QT corrected intervals and its dispersion, as well as clinical and laboratory parameters will be performed in 110 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be prospectively recruited with sequential electrocardiographic assessments .Their indication and dose will be prescribed at the discretion of the attending physician. The following data to be analyzed are: age, ethnicity, anthropometric data (height, weight and BMI), clinical indication for sotalol, prescribed dose, comorbidities, other concomitant drugs, biochemical analysis (urea, creatinine, estimated creatinine clearance as also sodium, potassium and magnesium serum levels), echocardiogram and Holter monitoring when indicated.

Participants must have a standard 12-lead electrocardiogram (25mm/s) available at the start of treatment, 2 hours after the first dose of medication, and after 3 days, to calculate the corrected QT interval (QTc) and to analyze the dispersion of this interval. The patient will remain in the hospital until the second electrocardiogram is performed.

The QT interval will be measured manually, from the beginning of the QRS to the end of the T wave, by the tangent method, in DII, V5 or V2, in this order of preference. The QTc interval dispersion will be calculated manually, considering the difference between the longest and the shortest QT interval measured in the conventional 12 leads ECG.

All measurements will be made by the same arrhythmologist and later confirmed by a second arrhythmologist. Any divergent measures will be resolved by consensus. If there is no agreement, a third arrhythmologist will analyse the data.

The clinical evolution of the patients (minimum period of 30 days) after the beginning of the medication will be evaluated via face-to-face consultation or by telephone contact. At that moment, the patient's medications, adherence to sotalol use and the occurrence of adverse events will be checked again.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Clinical Research Center of the Heart Institute - University of São Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco C Darrieux, MD, PhD
        • Sub-Investigator:
          • Alberto P Ferraz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication of sotalol for the treatment of any supraventricular or ventricular arrhythmias
  • Age ≥ 18 years
  • Provide written informed consent

Exclusion Criteria:

  • Complete bundle branch block
  • Bradycardia with a frequency less than or equal to 55 bpm
  • Ventricular pacing determined by artificial pacemaker
  • Corrected QT interval greater than or equal to 460ms
  • Heart failure with reduced ejection fraction, less than 40%
  • Lactation period
  • Dose required greater than 160 mg/day
  • Estimated creatinine clearance less than 60mL/min
  • Hypokalemia and hypomagnesemia documented in a patient at risk of spoliation of these components.
  • Concomitant use of other drugs with proarrhythmic potential related to increased corrected QT interval (eg, tricyclic antidepressants, macrolide antibiotics, electrolyte-depleting diuretics, etc.).
  • Others formal contraindications to the use of sotalol (e.g.: asthma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Consecutive patients elegible for outpatient sotalol indication
Single Group
Drug: Sotalol Oral Tablet
Dose of sotalol is prescribed by the attending physician. Accepted for this protocol when the dose is no greater than 160 mg/day
Other Names:
  • sotalol choridrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concerns about corrected QT prolongation after 72 hours.
Time Frame: 72 hours from the start of sotalol.
Number of participants with corrected QT interval increase greater than 10% of the baseline or beyond 500 milliseconds after 72 hours of introduction of sotalol.
72 hours from the start of sotalol.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concerns about corrected QT prolongation after 2 hours.
Time Frame: 2 hours after the initiation of sotalol.
Number of participants with corrected QT interval increase greater than 10% of the baseline or beyond 500 milliseconds after 2 hours of introduction of sotalol.
2 hours after the initiation of sotalol.
Side effects that can impair the maintenance of the drug.
Time Frame: 30 days of follow up.
Side effects that can influence the maintenance of the drug during the 30 days of follow up.
30 days of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Mauricio I Scanavacca, MD, PhD, Instituto do coração - HC/FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4947/19/166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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