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

October 25, 2006
March 21, 2007
January 2003
Not Provided
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
Same as current
Complete list of historical versions of study NCT00392431 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Number of patients with permanent AF at the end of the study
Same as current
Not Provided
Not Provided
 
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Persistant Atrial Fibrillation
Drug: amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00392431
2000B133
Not Provided
Not Provided
University Medical Centre Groningen
Netherlands Heart Foundation
Principal Investigator: Isabelle C Van Gelder, MD University Medical Centre Groningen
University Medical Centre Groningen
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP