Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation (NCT00392431) | Clinical Trial Compass
CompletedNot Applicable
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Netherlands220 participantsStarted 2003-01
Plain-language summary
Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
✓. Older than 18 years of age.
✓. Ventricular rate during AF \> 75 beats per minute, documented on rest-ECG without rate control.
✓. At least two weeks of oral anticoagulation therapy before screening.
✓. Written informed consent.
Exclusion criteria
✕. Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc \> 440ms).
✕. History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
✕. Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
✕. Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
What they're measuring
1
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease