Status:
COMPLETED
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electric...
Detailed Description
Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic ther...
Eligibility Criteria
Inclusion
- persistent Atrial Fibrillation (AF) lasting \> one month
- history of at least one AF relapse after previous electrical or Pharmacological cardioversion
Exclusion
- left atrium size \> 6 cm
- severe valvulopathy
- myocardial infarction during the previous 6 months
- unstable angina
- NYHA heart failure class IV or hemodynamic instability
- cardiac surgery during the previous 3 months
- significant pulmonary thyroid and hepatic disease
- contraindications to treatment with amiodarone or RASS inhibitors
- chronic renal dysfunction
- QT \> 480 msec in the absence of bundle-branch block
- bradycardia \< 50 b/min
- diagnosis of paroxysmal AF
- hyperkalemia
- pregnancy
- any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT01198275
Start Date
January 1 2006
End Date
May 1 2008
Last Update
January 20 2012
Active Locations (1)
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1
Arrhytmias and Heart failure Unit-Spedali Civili Hospital
Brescia, Brescia, Italy, 25100