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

NCT ID: NCT00845780

Last Updated: 2009-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2009-06-30

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

withdrawal amiodarone

withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy

Group Type: EXPERIMENTAL

withdrawal or continuation of amiodarone therapy

Intervention Type: DRUG

withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy

continuation amiodarone

continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy

Group Type: ACTIVE_COMPARATOR

withdrawal or continuation of amiodarone therapy

Intervention Type: DRUG

withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy

Interventions

withdrawal or continuation of amiodarone therapy

withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

University Medical Center Groningen

Principal Investigators

Isabelle C. Van Gelder, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

T377

Identifier Type: -

Identifier Source: org_study_id