This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial.
Author Raitt MH., Connor WE., Morris C., Kron J., Halperin B., Chugh SS., McClelland J., Cook J., MacMurdy K., Swenson R., Connor SL., Gerhard G., Kraemer DF., Oseran D., Marchant C., Calhoun D., Shnider R., McAnulty J.
Country Oregon Health and Science University, Portland, USA. merritt.raitt@med.va.gov
Year 2005
Numbers Pubmed ID: 15956633
15609 (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)
  • Comments Comments (
    0
    ) |
2 Placebo
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) US
  • Comments Comments (
    0
    ) |
Funding source No industry relationship reported (funding or affiliations reported)
  • Comments Comments (
    0
    ) |
Eligibility Criteria: eligible for entry if they were receiving an implantable cardioverter defibrillator (ICD) for an electrocardiogram-documented episode of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) that was not the result of acute myocardial infarction or a reversible cause or who had a preexisting ICD and had received ICD therapy for an episode of electrogramdocumented VT/VF within the previous 3 months
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Duration of Intervention 718 days (median)
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Arrhythmia ...
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... ejection fraction, CAD, VF at entry, VT at entry
  • Comments Comments (
    0
    ) |
Study start date(s) 2001
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 46 23
  • Comments Comments (
    0
    ) |
46 55
  • Comments Comments (
    0
    ) |
55 56
  • Comments Comments (
    0
    ) |
64 69
  • Comments Comments (
    0
    ) |
Baseline characteristics, continuous 63 62
  • Comments Comments (
    0
    ) |
13 13
  • Comments Comments (
    0
    ) |
Male, percent 86 86
  • Comments Comments (
    0
    ) |
Race 94 97
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description nd nd
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake No data entered.
Does this study report baseline omega-3 biomarker data? No No
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: arrhythmia      Population: 46164
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100
N without condition 100 100


180 days

N Enrolled 100 100
N without condition 55 64


360 days

N Enrolled 100 100
N without condition 47 55


540 days

N Enrolled 100 100
N without condition 35 46


720 days

N Enrolled 100 100
N without condition 21 24
Outcome: arrhythmia      Population: 46165
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100
N without condition 100 100


180 days

N Enrolled 100 100
N without condition 95 91


360 days

N Enrolled 100 100
N without condition 83 80


540 days

N Enrolled 100 100
N without condition 72 69


720 days

N Enrolled 100 100
N without condition 44 46
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100
N without condition 100 100


180 days

N Enrolled 100 100
N without condition 56 65


360 days

N Enrolled 100 100
N without condition 47 57


540 days

N Enrolled 100 100
N without condition 35 48


720 days

N Enrolled 100 100
N without condition 19 31
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled nd nd


720 days

N Enrolled nd nd
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled nd nd


720 days

N Enrolled nd nd
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 42 43
N without condition 42 43


180 days

N Enrolled 42 43
N without condition 28 33


360 days

N Enrolled 42 43
N without condition 25 30


540 days

N Enrolled 42 43
N without condition 17 25


720 days

N Enrolled 42 43
N without condition 10 16
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 55 55
N without condition 55 55


180 days

N Enrolled 55 55
N without condition 26 29


360 days

N Enrolled 55 55
N without condition 19 24


540 days

N Enrolled 55 55
N without condition 14 19


720 days

N Enrolled 55 55
N without condition 11 12
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 64 69
N without condition 64 69


180 days

N Enrolled 64 69
N without condition 26 43


360 days

N Enrolled 64 69
N without condition 22 37


540 days

N Enrolled 64 69
N without condition 14 30


720 days

N Enrolled 64 69
N without condition 18 8
Outcome: arrhythmia      Population: 46166
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled nd nd


720 days

N Enrolled nd nd
Outcome: Death      Population: 56403
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 2 5
Outcome: Death      Population: 56404
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 4 10
Outcome: arrhythmia      Population: 56405
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 2 0
Outcome: cardiac      Population: 56406
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 10 7
Outcome: cardiac      Population: 56408
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 14 12
Outcome: cv      Population: 56409
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 2 4
Outcome: cardiac      Population: 56410
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 days

N Enrolled 100 100


718 (median) days

N Enrolled 100 100
Counts 1 3

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Diarrhea 11 100 720 days
  • Comments Comments (
    0
    ) |
Placebo 12 100 720 days

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? LOW
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) No
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) LOW
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? Unsure
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table. LOW
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.