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Study Title and Description

Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial.
Author Brouwer IA., Zock PL., Camm AJ., Böcker D., Hauer RN., Wever EF., Dullemeijer C., Ronden JE., Katan MB., Lubinski A., Buschler H., Schouten EG.
Country Wageningen Centre for Food Sciences, Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. ingeborg.brouwer@wur.nl
Year 2006
Numbers Pubmed ID: 16772624
16822 (internal)

Secondary Publication Information
UI Title Author Country Year
Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. Brouwer IA., Zock PL., Wever EF., Hauer RN., Camm AJ., Böcker D., Otto-Terlouw P., Katan MB., Schouten EG. Wageningen Centre for Food Sciences (WCFS), Wageningen, The Netherlands. Ingeborg.Brouwer@staff.NutEpi.wau.nl 2003
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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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What is the name of this study? (e.g. DART, Physician's Health Study) SOFA trial
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Country in which study conducted (where subjects live) Germany
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Netherlands
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Sweden
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UK
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Other(s) [Separate countries with commas]: ... Poland, Czech Republic, Belgium, Austria
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: men and women >=18 years old, experienced at least 1 true, confirmed, spontaneous VT or VF in the preceding year, and either had and ICD or were about to receive one. Exclusion: receipt of an ICD for prophylactic reasons; ICD as a "bridge" to heart transplantation; refractory supraventricular arrhythmia with rapid ventricular rates despite antiarrhythmic therapy; a projected life span of <1 year; use of supplemental omega-3 PUFA during the past 3 months or consumption >8g of omega-3 PUFAs from fish or seafood per month (267 mg/d) as judged by a seafood FFQ; pregnant women; women of childbearing age who did not use adequate contraception, and patients with a known history of recent drug or alcohol abuse.
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Comment about Eligibility Criteria: excluded patients with high baseline omega-3 intake from supplements and/or foods
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 12 months
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Arrhythmia ... at least 1 true, confirmed, spontaneous VT or VF in the preceding year, and either had and ICD or were about to receive one.
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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 ... VT as Index Arrhythmia, VF as Index Arrhythmia, prior MI, EF<=30% at entry, no antiarrhythmic agents
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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) 2001
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 17 15
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53 49
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>=160/95 mm Hg in repeated measurements, or patients taking antihypertensive medication >=160/95 mm Hg in repeated measurements, or patients taking antihypertensive medication
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73 79
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ischemic heart disease ischemic heart disease
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26 25
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AFib AFib
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75 76
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Baseline characteristics, continuous 60.5 62.4
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12.8 11.4
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122.2 121.2
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18.8 18.5
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73.4 74.2
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10.8 9.1
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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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26.98 26.86
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4.4 4.01
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nd nd
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Male, percent 85 84
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Race 100 100
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assumed from inclusino criteria assumed from inclusino criteria
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Comments about baseline data complete baseline biomarkers data probably reported in reference 26
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Baseline diet description No data entered.
Baseline omega-3 intake patients with high baseline omega-3 intake from supplements and/or foods were excluded (> 8 g of omega-3 PUFA based on FFQ)
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Does this study report baseline omega-3 biomarker data? Yes No
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Results & Comparisons


Results Data
Outcome: Death      Population: 53401
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 8 15
N Analyzed 273 273
Proportion 3 5
Outcome: Death      Population: 53402
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 6 13
N Analyzed 273 273
Proportion 2 5
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 81 90
N Analyzed 273 273
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 47 58
N Analyzed 149 153
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 8 9
N Analyzed 41 43
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 47 61
N Analyzed 162 171
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 29 36
N Analyzed 87 95
Outcome: arrhythmia      Population: 53403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 36 43
N Analyzed 97 116
Outcome: arrhythmia      Population: 53406
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 3 3
N Analyzed 273 273
Proportion 1 1
Outcome: cardiac      Population: 53407
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 1 3
N Analyzed 273 273
Proportion 0.4 1
Outcome: arrhythmia      Population: 53404
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 75 81
N Analyzed 273 273
Outcome: arrhythmia      Population: 53405
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

Counts 72 78
N Analyzed 273 273

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Cardiac cause angina, heart failure, arrhythmia, or other cardiac cause) 65 273 1 year
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Placebo 62 273 1 year
"Fish oil" (DHA+EPA) angina 10 273 1 year
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Placebo 12 273 1 year
"Fish oil" (DHA+EPA) heart failure 22 273 1 year
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Placebo 19 273 1 year
"Fish oil" (DHA+EPA) arrhythmia 36 273 1 year
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Placebo 34 273 1 year
"Fish oil" (DHA+EPA) other cardiac cause 20 273 1 year
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Placebo 19 273 1 year
"Fish oil" (DHA+EPA) cancer/malignancies 4 273 1 year
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Placebo 4 273 1 year
"Fish oil" (DHA+EPA) gastrointestinal 17 273 1 year
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Placebo 12 273 1 year
"Fish oil" (DHA+EPA) liver problems 3 273 1 year
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Placebo 1 273 1 year

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 Low
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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) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? Yes
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. No
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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 No
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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 Low
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Quality Rating
Guideline Used Overall Rating