Status:
UNKNOWN
Safety Assessment for Sotalol Protocol in Outpatient Unit
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Supraventricular Arrhythmia
Ventricular Arrythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 introduct...
Detailed Description
Participants will be prospectively recruited with sequential electrocardiographic assessments .Their indication and dose will be prescribed at the discretion of the attending physician. The following ...
Eligibility Criteria
Inclusion
- Indication of sotalol for the treatment of any supraventricular or ventricular arrhythmias
- Age ≥ 18 years
- Provide written informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05418036
Start Date
October 26 2020
End Date
June 1 2023
Last Update
July 11 2022
Active Locations (1)
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1
Clinical Research Center of the Heart Institute - University of São Paulo
São Paulo, Brazil, 05403-900