NCT00392431

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (planned)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective 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: 1. amiodarone use 2. atrial fibrillation itself or underlying heart disease. Secondary objective 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.

Conditions

• Persistant Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	amiodarone

Timeline

• Start date: 2003-01-01
• Completion: 2007-03-01
• First posted: 2006-10-26
• Last updated: 2007-03-22

Locations

1 site across 1 country: Netherlands