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Safety Assessment for Sotalol Protocol in Outpatient Unit

NCT05418036 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-07-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Mauricio I Scanavacca, MD, PhD · Instituto do Coração - HC/FMUSP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2023-02-28
Completion
2023-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418036 on ClinicalTrials.gov