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Safety Assessment for Sotalol Protocol in Outpatient Unit

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05418036
Collaborator
(none)
110
Enrollment
1
Location
1
Arm
31.1
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sotalol Oral Tablet
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective studyProspective study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety Assessment for Sotalol Protocol in Outpatient Unit
Actual Study Start Date :
Oct 26, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concerns about corrected QT prolongation after 72 hours. [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.

    Secondary Outcome Measures

    1. Concerns about corrected QT prolongation after 2 hours. [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. Side effects that can impair the maintenance of the drug. [30 days of follow up.]

      Side effects that can influence the maintenance of the drug during the 30 days of follow up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of the Heart Institute - University of São Paulo São Paulo Brazil 05403-900

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mauricio Ibrahim Scanavacca, Arrhythmia Clinical Unit Director, University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT05418036
    Other Study ID Numbers:
    • 4947/19/166
    First Posted:
    Jun 14, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mauricio Ibrahim Scanavacca, Arrhythmia Clinical Unit Director, University of Sao Paulo General Hospital
    Sotalol
    Drug Safety
    Corrected QT interval
    Outpatient Treatment
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac
    Drug-Related Side Effects and Adverse Reactions
    Sotalol

    Study Results

    No Results Posted as of Jul 11, 2022