Safety Assessment for Sotalol Protocol in Outpatient Unit

NCT05418036 | Unknown Phase 4

• 1 other identifier: 4947/19/166
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraventricular Arrhythmia; Ventricular Arrythmia; Proarrhythmia; Antiarrhythmic Drug Adverse Reaction

Keywords

Sotalol; Drug Safety; Corrected QT interval; Outpatient Treatment

Outcome Measures

Primary Outcomes (1)

• Concerns about corrected QT prolongation after 72 hours.

  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 Outcomes (2)

• Concerns about corrected QT prolongation after 2 hours.

  2 hours after the initiation of sotalol.

• Side effects that can impair the maintenance of the drug.

  30 days of follow up.

Study Arms (1)

Consecutive patients elegible for outpatient sotalol indication

OTHER

Single Group

Drug: Sotalol Oral Tablet

Interventions

Sotalol Oral Tablet DRUG

Dose of sotalol is prescribed by the attending physician. Accepted for this protocol when the dose is no greater than 160 mg/day

Also known as: sotalol choridrate

Consecutive patients elegible for outpatient sotalol indication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Clinical Research Center of the Heart Institute - University of São Paulo

São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (31)

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MeSH Terms

Interventions

Sotalol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Mauricio I Scanavacca, MD, PhD

  Instituto do Coração - HC/FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco CC Darrieux

CONTACT

+ 55 11 26615341; frdarrieux@gmail.com

Alberto P Ferraz

CONTACT

albertopferraz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Clinical Unit Director

Model Details: Prospective study

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: October 26, 2020
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)