Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Persistent Atrial Fibrillation
Intervention: withdrawal or continuation of amiodarone therapy (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Isabelle C. Van Gelder, MD PhD, Principal Investigator, Affiliation: University Medical Center Groningen
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.
Clinical Details
Official title: Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: occurrence of late relapse of persistent atrial fibrillation
Secondary outcome: difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University Medical Center Groningen, Groningen 9700 RB, Netherlands
Additional Information
Starting date: August 2000
Last updated: June 23, 2009
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