Clinical trial NCT00845780: Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
Official title: Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
amiodarone
late recurrence atrial fibrillation
adverse events
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: occurrence of late relapse of persistent atrial fibrillation
timeFrame: 2 years
Secondary outcomes:
measure: difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Isabelle C. Van Gelder, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: