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

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Persistent Atrial Fibrillation

Intervention: withdrawal or continuation of amiodarone therapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Isabelle C. Van Gelder, MD PhD, Principal Investigator, Affiliation: University Medical Center Groningen


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: occurrence of late relapse of persistent atrial fibrillation

Secondary outcome: difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- history of persistent atrial fibrillation, necessitating at least one electrical


- 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


- recent myocardial infarction (< 3 months)

- presence of any disease that is likely to shorten life expectancy to < 1 year

Locations and Contacts

University Medical Center Groningen, Groningen 9700 RB, Netherlands
Additional Information

Starting date: August 2000
Last updated: June 23, 2009

Page last updated: August 23, 2015

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