Safety Assessment for Sotalol Protocol in Outpatient Unit (NCT05418036) | Clinical Trial Compass
UnknownPhase 4
Safety Assessment for Sotalol Protocol in Outpatient Unit
Brazil110 participantsStarted 2020-10-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concerns about corrected QT prolongation after 72 hours.