Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation (WISDOM)
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
withdrawal or continuation of amiodarone therapy
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events
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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
withdrawal amiodarone
continuation amiodarone
Arm Description
withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy
continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy
Outcomes
Primary Outcome Measures
occurrence of late relapse of persistent atrial fibrillation
Secondary Outcome Measures
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
Full Information
NCT ID
NCT00845780
First Posted
February 17, 2009
Last Updated
June 23, 2009
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT00845780
Brief Title
Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
Acronym
WISDOM
Official Title
Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
withdrawal amiodarone
Arm Type
Experimental
Arm Description
withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy
Arm Title
continuation amiodarone
Arm Type
Active Comparator
Arm Description
continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy
Intervention Type
Drug
Intervention Name(s)
withdrawal or continuation of amiodarone therapy
Intervention Description
withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy
Primary Outcome Measure Information:
Title
occurrence of late relapse of persistent atrial fibrillation
Time Frame
2 years
Secondary Outcome Measure Information:
Title
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle C. Van Gelder, MD PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
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Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
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