Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.

Official Title
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Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Drug: withdrawal or continuation of amiodarone therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of persistent atrial fibrillation, necessitating at least one electrical cardioversion presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone clinically stable age > 18 years written informed consent Exclusion Criteria: sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason) symptomatic heart failure NYHA III or IV unstable angina pectoris hemodynamically significant valvular disease concomitant treatment with other class I or III antiarrhythmic drug PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months recent myocardial infarction (< 3 months) presence of any disease that is likely to shorten life expectancy to < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: withdrawal amiodarone<br>withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy | Drug: withdrawal or continuation of amiodarone therapy<br>* withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy<br>|
| Active Comparator: continuation amiodarone<br>continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy | Drug: withdrawal or continuation of amiodarone therapy<br>* withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of late relapse of persistent atrial fibrillation |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events