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Study Title and Description

Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake.
Author Leaf A., Albert CM., Josephson M., Steinhaus D., Kluger J., Kang JX., Cox B., Zhang H., Schoenfeld D.
Country Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. aleaf@partners.org
Year 2005
Numbers Pubmed ID: 16267249
15613 (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 olive oil
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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) US
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: Subjects were included who had an ICD implanted because of a history of cardiac arrest, sustained ventricular tachycardia (VT), or syncope with inducible, sustained VT or ventricular fibrillation (VF) during electrophysiologic studies. The qualifying ICD implantation was required to have occurred within 12 months before entry into the study or if the patient had experienced at least 1 spontaneous ICD event for VT/VF in the preceding 12 months.
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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: Arrhythmia ... ICD implanted
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... sex, congestive heart failure New York Heart Association class, baseline blood levels of n-3 fatty acid, or indication for the ICD, LVEF, history of coronary artery disease
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 1999
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 76 81
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coronary artery disease coronary artery disease
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18 18.8
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history of AFib history of AFib
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Baseline characteristics, continuous 65.7 65.3
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0.82 0.82
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ND ND
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ND ND
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ND ND
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ND ND
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ND ND
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ND ND
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ND ND
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ND ND
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ND ND
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Male, percent 84.5 81.7
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Race 95.5 96.5
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white white
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Comments about baseline data No data entered.
Baseline diet description Grains, fruits, vegetables, and legumes composed the other constituents of the prescribed diet. Eighty-seven percent of participants reported complying with these dietary recommendations for the duration of the trial.
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Baseline omega-3 intake Subjects were asked to consume no more than 2 fish meals per month. Eighty-seven percent of participants reported complying with these dietary recommendations for the duration of the trial
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: Death      Population: 46185
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 200 202
Counts 13 12
Outcome: Death      Population: 46186
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 200 202
Counts 9 9
Outcome: arrhythmia      Population: 46187
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 200 202
Counts 3 1
Outcome: arrhythmia      Population: 46188
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 200 202
Counts 57 78
Percentage 28 39
Outcome: arrhythmia      Population: 46188
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 200 202
Counts
Percentage

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) No adverse events There were no serious events in either cohort attributable to the prescribed oil supplements. 200
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Placebo 202

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)? UNCLEAR
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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 LOW
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? LOW
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? Yes
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Group SIMILARITY AT BASELINE (**OMEGA-3**) LOW
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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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
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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
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Quality Rating
No quality rating data was found.