Safety Assessment for Sotalol Protocol in Outpatient Unit
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.