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

Phase 4

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Drug: withdrawal or continuation of amiodarone therapy

• Registration Number: NCT00845780
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
withdrawal amiodarone	withdrawal or continuation of amiodarone therapy	withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy
continuation amiodarone	withdrawal or continuation of amiodarone therapy	continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy

Primary Outcome Measures

Name	Time	Method
occurrence of late relapse of persistent atrial fibrillation	2 years

Secondary Outcome Measures

Name	Time	Method
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies	2 years

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands