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

This study has been completed.
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00392431
First received: October 25, 2006
Last updated: March 21, 2007
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention
Persistant Atrial Fibrillation
 Drug: amiodarone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease

Secondary Outcome Measures:
  • Quality of life
  • Number of patients with permanent AF at the end of the study

Estimated Enrollment: 220
Study Start Date: January 2003
Study Completion Date: March 2007
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.

  Eligibility

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

Inclusion criteria:

  1. Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
  2. Older than 18 years of age.
  3. Ventricular rate during AF > 75 beats per minute, documented on rest-ECG without rate control.
  4. At least two weeks of oral anticoagulation therapy before screening.
  5. Written informed consent.

Exclusion criteria:

  1. Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc > 440ms).
  2. History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
  3. Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
  4. Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
  5. First episode of persistent atrial fibrillation.
  6. More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
  7. Known sick sinus syndrome.
  8. History of second or third degree AV conduction disturbances.
  9. Intraventricular conduction disturbances (QRS> 140ms).
  10. Pacemaker treatment.
  11. Hemodynamically significant valvular disease.
  12. Patients with heart failure with symptoms according to NYHA class III or IV.
  13. Unstable angina pectoris.
  14. Recent myocardial infarction (< 3 months).
  15. PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
  16. History of hyperthyroidism or hypothyroidism.
  17. Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
  18. Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
  19. Treatment with any other investigational agent.
  20. Presence of any disease that is likely to shorten life expectancy to < 1 year.
  21. Any condition that in the opinion of the investigator would jeopardise the evaluation of efficacy or safety or be associated with poor adherence to the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392431

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

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00392431     History of Changes
Other Study ID Numbers: 2000B133
Study First Received: October 25, 2006
Last Updated: March 21, 2007
Health Authority: European Union: European Medicines Agency

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 June 18, 2013