Persistent atrial fibrillation
Conditions
Brief summary
First recurrence of AF (requires ECG) after randomization.
Detailed description
Assessment of adverse effects, which will be determined by specific criteria including TSH levels below 0.1 microUI/ml, TSH levels exceeding 4.2 microUI/ml, a threefold increase in AST, ALT, or GGT compared to baseline levels, a QTc interval exceeding 500 ms or any other adverse effects as per the drug technical sheet., Study of polymorphisms in CYP2D6, CYP2C19, CYP1A2, CYP2C8, CYP3A4, and ABCB1., Plasma levels of amiodarone during follow-up, Correlate polymorphisms, with plasma levels, safety and efficacy.
Interventions
DRUGAmiodarone hydrochloride 200 mg tablets
Sponsors
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First recurrence of AF (requires ECG) after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of adverse effects, which will be determined by specific criteria including TSH levels below 0.1 microUI/ml, TSH levels exceeding 4.2 microUI/ml, a threefold increase in AST, ALT, or GGT compared to baseline levels, a QTc interval exceeding 500 ms or any other adverse effects as per the drug technical sheet., Study of polymorphisms in CYP2D6, CYP2C19, CYP1A2, CYP2C8, CYP3A4, and ABCB1., Plasma levels of amiodarone during follow-up, Correlate polymorphisms, with plasma levels, safety and efficacy. | — |
Countries
Spain
Outcome results
None listed