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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00845780
First received: February 17, 2009
Last updated: June 23, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Persistent Atrial Fibrillation
 Drug: withdrawal or continuation of amiodarone therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • occurrence of late relapse of persistent atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: August 2000
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845780

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Isabelle C. Van Gelder, MD PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Prof Dr I.C. Van Gelder, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00845780     History of Changes
Other Study ID Numbers: T377
Study First Received: February 17, 2009
Last Updated: June 23, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
persistent atrial fibrillation
amiodarone
late recurrence atrial fibrillation
adverse events

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013