Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life|
- Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
- Quality of life
- Number of patients with permanent AF at the end of the study
|Study Start Date:||January 2003|
|Study Completion Date:||March 2007|
To determine differences in adverse event rates between patients with persistent atrial fibrillation who are randomized to episodic amiodarone treatment (EAT) strategy and patients who are randomized to continuous amiodarone treatment (CAT) strategy, while atrial fibrillation is still effectively suppressed.
Adverse events can be related to:
- amiodarone use
- atrial fibrillation itself or underlying heart disease.
To determine differences in quality of life between patients with persistent atrial fibrillation who are randomized to the EAT strategy and patients who are randomized to the CAT strategy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392431
|University Medical Center Groningen|
|Groningen, Netherlands, 9700RB|
|Principal Investigator:||Isabelle C Van Gelder, MD||University Medical Centre Groningen|