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Completed

NCT Number: NCT00845780

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

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

withdrawal or continuation of amiodarone therapy

Drug

withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy

Primary outcomes

  1. occurrence of late relapse of persistent atrial fibrillation

    Time frame: 2 years

Secondary outcomes

  1. difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: WISDOM

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2009
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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