Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amiodarone Hydrochloride 200 MG, Amiodarone Hydrochloride 100 MG.
- Who it may be relevant to
- Registry conditions: Persistent Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
Overview
\--- 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.
Interventions
- Drug Amiodarone Hydrochloride 200 MG
Patients will receive full amiodarone daily doses: 200 mg/day - Drug Amiodarone Hydrochloride 100 MG
Patients will receive amiodarone reduced daily doses: 100 mg/d
Primary outcome measures
- Maintenance of sinus rhythm [Time frame: 12 months follow-up]
Secondary outcome measures (3)
- Adverse effects [Time frame: 12 months follow-up]
- Polymorphisms [Time frame: 12 months follow-up]
- Plasma levels [Time frame: 12 months follow-up]
Eligibility criteria
Inclusion criteria
- Patients aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
Exclusion criteria
- Urgent electrical cardioversion
- Atrial fibrillation post-cardiac surgery
- Previous myocardial infarction
- New York Heart Association (NYHA) Class IV heart failure
- Left ventricular ejection fraction (LVEF) <45%
- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
- Hyperthyroidism or hypothyroidism
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)
- Allergy, intolerance, or known hypersensitivity to study medications
- Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
- Participation in another clinical trial involving investigational drugs
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
- 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.
- Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm
- 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.
- Patient do not have a smart mobile phone or do not know how to use it adequately.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital de la Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT07273994 · IIBSP-AMI-2024-33 · Project PI023/1768 · 2024-514113-35-00