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Study Title and Description

n-3 polyunsaturated fatty acids in the prevention of atrial fibrillation recurrences after electrical cardioversion: a prospective, randomized study.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title n-3 polyunsaturated fatty acids in the prevention of atrial fibrillation recurrences after electrical cardioversion: a prospective, randomized study.
Author Nodari S., Triggiani M., Campia U., Manerba A., Milesi G., Cesana BM., Gheorghiade M., Dei Cas L.
Country Department of Experimental and Applied Medicine, Section of Cardiovascular Diseases, University of Brescia Medical School, P. le Spedali Civili, 1-25123 Brescia, Italy.
Year 2011
Numbers Pubmed ID: 21844082
15608 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA)
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2 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) Italy
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Patients with persistent AFib lasting 1 month and confirmed by 24-hour ECG Holter monitoring and history of at least 1 relapse after previous successful cardioversion. Exclusion criteria included left atrial size 60 mm; severe valvulopathy; myocardial infarction during the previous 6 months; unstable angina; New York Heart Association class IV heart failure; hemodynamic instability; cardiac surgery during the previous 3 months; significant pulmonary, thyroid, or hepatic disease; contraindication to treatment with amiodarone, ACE-I, or ARB; chronic kidney disease; hyperkalemia; pregnancy; and any disease or condition that, in the opinion of the investigators, could interfere with safety or study results.
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 1 year
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Other ... persistent fibrillation
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Does the study report a subgroup analysis for an outcome of interest? No ejection fraction, CAD, VF at entry, VT at entry
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Study start date(s) 2006
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 36 33.6
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47 40.4
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Baseline characteristics, continuous 70 69
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6 9
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134 136
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20 16
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82 82
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10 9
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23.8 23.6
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5.2 5.3
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77.0 76.5
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Kg Kg
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12.8 10.1
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Male, percent 70.0% 63.6%
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Race nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? No No
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Results & Comparisons


Results Data
Outcome: arrhythmia      Population: 45921
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 99


718 (median) days

N Enrolled 100 99
Counts 15 25
Outcome: arrhythmia      Population: 45922
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 99


718 (median) days

N Enrolled 100 99
Counts 37 56

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse Event 1 1 amiodarone toxicity related to asymptomatic abnormal thyroid function tests nd 100
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Placebo nd 99
"Fish oil" (DHA+EPA) Adverse Event 1 3 amiodarone toxicity related to symptomatic abnormal thyroid function tests nd 100
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Placebo nd 99
"Fish oil" (DHA+EPA) Adverse Event 1 1 mildly abnormal respiratory function tests nd 100
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Placebo nd 99

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
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Was ALLOCATION adequately concealed (prior to assignment)? LOW
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Were PARTICIPANTS adequately BLINDED? LOW
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Were OUTCOME ASSESSORS adequately BLINDED? LOW
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Unsure
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) No
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? Unsure
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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Additional Bias: Bias due to problems not covered elsewhere in the table. LOW
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes LOW
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes Unsure
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Quality Rating
No quality rating data was found.