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Study Title and Description

Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial.
Author Macchia A., Grancelli H., Varini S., Nul D., Laffaye N., Mariani J., Ferrante D., Badra R., Figal J., Ramos S., Tognoni G., Doval HC.
Country Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina. macchia@negrisud.it
Year 2013
Numbers Pubmed ID: 23265344
15607 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo
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2 "Fish oil" (DHA+EPA)
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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) FORWARD
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Country in which study conducted (where subjects live) Italy
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Other(s) [Separate countries with commas]: ... Argentina
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Funding source Industry funded
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Eligibility Criteria: patients with previous persistent AF (>=2 symptomatic episodes of documented AF in the 6 months before randomization, with last episode occurring within 3 to 90 days before randomization (paroxysmal AF); or successful electrical or pharmacological cardioversion for persistent AF performed within 3 to 28 days before randomization
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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 ...
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... gender, age, duration of AF
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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) 2008
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 14.7 11.1
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90.8 92.2
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14.3 13.9
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4.4 5.0
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100 100
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Baseline characteristics, continuous 65.9 66.3
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10.5 12.0
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83 81
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Kg Kg
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19 16
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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 51.9% 57.8%
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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: Death      Population: 45792
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Counts 5 4
Percentage 1.7 1.4
Outcome: composite      Population: 45793
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Counts 20 16
Percentage 6.7 5.5
Outcome: cardiac      Population: 45794
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Counts 1 1
Percentage 0.3 0.3
Outcome: cerebro      Population: 45795
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Counts 3 3
Percentage 1.0 1.0
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Counts 56 69
Percentage 18.9 23.9
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: arrhythmia      Population: 45813
Time Point Measure Placebo "Fish oil" (DHA+EPA)


0 months

N Enrolled 297 289


12 months

N Enrolled 297 289
Outcome: cardiac      Population: 45820
Time Point Measure Placebo "Fish oil" (DHA+EPA)


12 months

N Enrolled 297 289
Counts 6 5
Percentage 2.0 1.7

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo nd
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"Fish oil" (DHA+EPA)

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure
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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.