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Study Title and Description

Effects of n-3 polyunsaturated fatty acids on left ventricular function and functional capacity in patients with dilated cardiomyopathy.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of n-3 polyunsaturated fatty acids on left ventricular function and functional capacity in patients with dilated cardiomyopathy.
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, Brescia, Italy.
Year 2011
Numbers Pubmed ID: 21215550
18367 (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 Data on funding or affiliations
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Eligibility Criteria: Patients aged between 18 and 75 years with a diagnosis of NICM, LV systolic dysfunction (defined as an EF 45%), and stable clinical conditions with minimal or no symptoms for at least 3 months on evidence-based medical treatment at maximum tolerated target doses for at least 6 months were considered eligible for the study. The following criteria were grounds for exclusion: presence of symptoms or evidence of coronary artery disease diagnosed through noninvasive tests, peripheral arterial disease, presence of congenital or primary valvular heart disease, persistent atrial fibrillation, inability to perform bicycle ergometry for noncardiac causes, moderately to severely reduced functional capacity, NYHA functional class IV, poor acoustic windows limiting the ability to assess echocardiographic measurements, chronic lung disease, advanced renal disease (estimated glomerular filtration rate [eGFR] <= 30 ml/min/1.73 m^2), advanced liver disease; any disease limiting life expectancy to <=1 year, contraindications to study drugs, and concomitant participation in other research studies.
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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: Other ... mild and moderate heart failure (HF) due to nonischemic dilated cardiomyopathy (NICM)
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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? No
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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? Yes
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Study start date(s) 2007
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 10.4 23
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Baseline characteristics, continuous 61 64
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11 9
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119.5 120.5
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9.2 12.2
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76.0 76.2
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5.2 5.1
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25.9 25.7
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2.3 2.22
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76.9 76.0
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Kg 7.5
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10.1 187
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187 mg/dL
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mg/dL 28
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26 154
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149 mg/dL
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mg/dL 76
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62
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Male, percent 95.5 84.9
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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: bp      Population: 52268
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed 67 66
Mean 76 76
SD 5 5
SE


12 months

N Analyzed 67 66
Mean 75 76
SD 4 5
SE
Outcome: bp      Population: 52269
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed 67 66
Mean 119 120
SD 9 12
SE


12 months

N Analyzed 67 66
Mean 121 119
SD 6 11
SE
Outcome: lipid      Population: 52270
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed 67 66
Mean 149 154
SD 62 76
SE


12 months

N Analyzed 67 66
Mean 143 155
SD 45 69
SE

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure just says subjects were "randomized" but not how.
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Was ALLOCATION adequately concealed (prior to assignment)? Unsure
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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? Low
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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. 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 Unsure
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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
No quality rating data was found.