Two amiodarone doses to keep normal heart rhythm after shock treatment in atrial fibrillation
Compares two amiodarone doses to keep the heartbeat regular in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
Key facts
- Where
- Badalona, Barcelona, Reus, and Santiago de Compostela, SpainSee the 4 sites
- Phase
- Phase 4
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Salut Sant Joan de ReusReus, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Trial code
- NCT07273994EU 2024-514113-35-01
- Record updated
- 10 December 2025
- Original description
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Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
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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.
Inclusion: Patients aged ≥ 18 years; Documented persistent atrial fibrillation (≥ 7 days in duration); Electively referred for Electrical Cardioversion; Signed informed consent.
Exclusion: Previous myocardial infarction; Participation in another clinical trial involving investigational drugs; Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm; Atrial fibrillation post-cardiac surgery; New York Heart Association (NYHA) Class IV heart failure; Allergy, intolerance, or known hypersensitivity to study medications; Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity; Left ventricular ejection fraction (LVEF) <45%; Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN); Patients with abnormal baseline QTc (>450 ms in males and >470 in females) or abnormal ECG that precludes QTc assessment; Patients requiring concomitant medications that have a higher risk of QTc prolongation; Urgent electrical cardioversion; Significant left ventricular hypertrophy (wall thickness ≥ 15mm); Hyperthyroidism or hypothyroidism; Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women; Life expectancy less than 12 months; Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction; Patient do not have a smart mobile phone or do not know how to use it adequately.