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

Not Applicable

Completed

• Conditions: Persistant Atrial Fibrillation

• Registration Number: NCT00392431
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Status Verified: 2007-03
• Study Completion: 2007-03
• Last Update Submitted: 2007-03-21
• Last Update Posted: 2007-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease

Secondary Outcome Measures

Name	Time	Method
Quality of life
Number of patients with permanent AF at the end of the study

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands