RecruitingPhase 4NCT07273994

Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation

Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation


Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Enrollment

312 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

\--- 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different dose schedules of amiodarone — a medication used to maintain a normal heart rhythm — in patients with persistent atrial fibrillation (AFib lasting 7 or more days) who are having an electrical cardioversion procedure (a controlled electric shock to reset the heart rhythm). **You may be eligible if...** - You are 18 or older - You have persistent atrial fibrillation lasting at least 7 days - You are scheduled for an elective (planned) cardioversion procedure - You have signed informed consent **You may NOT be eligible if...** - You need emergency cardioversion - Your AFib developed after heart surgery - You have had a previous heart attack - You have severe heart failure symptoms (NYHA class IV) - You have a known allergy or intolerance to amiodarone - You have a thyroid condition, severe lung disease, or significant liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmiodarone Hydrochloride 200 MG

Patients will receive full amiodarone daily doses: 200 mg/day

DRUGAmiodarone Hydrochloride 100 MG

Patients will receive amiodarone reduced daily doses: 100 mg/d


Locations(1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT07273994


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