Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation (WISDOM)

Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Drug: withdrawal or continuation of amiodarone therapy

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: withdrawal amiodarone; withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy	Drug: withdrawal or continuation of amiodarone therapy; withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy
Active Comparator: continuation amiodarone; continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy	Drug: withdrawal or continuation of amiodarone therapy; withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence of late relapse of persistent atrial fibrillation	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies	2 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Isabelle C. Van Gelder, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2009
• Last Update Submitted That Met QC Criteria: June 23, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: adverse events; amiodarone; persistent atrial fibrillation; late recurrence atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: T377