Status:
COMPLETED
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Netherlands Heart Foundation
Conditions:
Persistant Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 compa...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
- Older than 18 years of age.
- Ventricular rate during AF \> 75 beats per minute, documented on rest-ECG without rate control.
- At least two weeks of oral anticoagulation therapy before screening.
- Written informed consent.
- Exclusion criteria:
- Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc \> 440ms).
- History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
- Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
- Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
- First episode of persistent atrial fibrillation.
- More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
- Known sick sinus syndrome.
- History of second or third degree AV conduction disturbances.
- Intraventricular conduction disturbances (QRS\> 140ms).
- Pacemaker treatment.
- Hemodynamically significant valvular disease.
- Patients with heart failure with symptoms according to NYHA class III or IV.
- Unstable angina pectoris.
- Recent myocardial infarction (\< 3 months).
- PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
- History of hyperthyroidism or hypothyroidism.
- Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
- Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
- Treatment with any other investigational agent.
- Presence of any disease that is likely to shorten life expectancy to \< 1 year.
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00392431
Start Date
January 1 2003
End Date
March 1 2007
Last Update
March 22 2007
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9700RB