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

Persistent Atrial Fibrillation Clinical Trial

— WISDOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845780
• Other study ID #: T377
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2009
• Last updated: June 23, 2009
• Start date: August 2000
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of late relapse of persistent atrial fibrillation		2 years	No
Secondary	difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies		2 years	Yes