About this trial
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The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
* Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion? * What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion? * How do genetic polymorphisms affect the efficacy and safety of amiodarone? * How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
* Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion. * Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years
Documented persistent atrial fibrillation (≥ 7 days in duration)
Electively referred for Electrical Cardioversion
Signed informed consent.
Disqualifiers
Urgent electrical cardioversion
Atrial fibrillation post-cardiac surgery
Previous myocardial infarction
New York Heart Association (NYHA) Class IV heart failure
Trial design
Parallel
Treatments tested in this trial
Amiodarone Hydrochloride 200 MG
DrugPatients will receive full amiodarone daily doses: 200 mg/day
Amiodarone Hydrochloride 100 MG
DrugPatients will receive amiodarone reduced daily doses: 100 mg/d
Treatment groups
Trial outcomes
Primary outcomes
Maintenance of sinus rhythm
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion
Secondary outcomes
Adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Polymorphisms
Association of the different assessed polymorphisms with the primary and first secondary outcome
Plasma levels
Correlation of amiodarone plasma levels during follow-up with the maintenance of sinus rhythm
Other outcomes
Plasma levels - polymorphisms
Correlation of amiodarone plasma levels with polymorphisms
Sponsors and contacts
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Instituto de Salud Carlos III
Collaborator