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

University Medical Center Groningen (UMCG)

Status and phase

Completed

Phase 4

Conditions

Persistent Atrial Fibrillation

Treatments

Drug: withdrawal or continuation of amiodarone therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00845780

T377

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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