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

NCT00845780 | Completed Phase 4

• 1 other identifier: T377
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Keywords

persistent atrial fibrillation; amiodarone; late recurrence atrial fibrillation; adverse events

Outcome Measures

Primary Outcomes (1)

• occurrence of late relapse of persistent atrial fibrillation

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

withdrawal amiodarone

EXPERIMENTAL

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

Drug: withdrawal or continuation of amiodarone therapy

continuation amiodarone

ACTIVE COMPARATOR

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

Drug: withdrawal or continuation of amiodarone therapy

Interventions

withdrawal or continuation of amiodarone therapy DRUG

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

continuation amiodarone; withdrawal amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle C. Van Gelder, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: August 1, 2000
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

NL (1)