Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Information source: University Medical Centre Groningen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Persistant Atrial Fibrillation
Intervention: amiodarone (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Medical Centre Groningen Official(s) and/or principal investigator(s):
Isabelle C Van Gelder, MD, Principal Investigator, Affiliation: University Medical Centre Groningen
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
Secondary outcome: Quality of lifeNumber of patients with permanent AF at the end of the study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University Medical Center Groningen, Groningen 9700RB, Netherlands
Additional Information
Starting date: January 2003
Ending date: March 2007
Last updated: March 21, 2007
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