Safety Assessment for Sotalol Protocol in Outpatient Unit

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Sotalol

Criteria

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)