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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00392431
First Posted: October 26, 2006
Last Update Posted: March 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Center Groningen
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by University Medical Center 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392431


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00392431     History of Changes
Other Study ID Numbers: 2000B133
First Submitted: October 25, 2006
First Posted: October 26, 2006
Last Update Posted: March 22, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors


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