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Study Title and Description

Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled 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 n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.
Author Tavazzi L., Maggioni AP., Marchioli R., Barlera S., Franzosi MG., Latini R., Lucci D., Nicolosi GL., Porcu M., Tognoni G.
Country -- Not Found --
Year 2008
Numbers Pubmed ID: 18757090
15606 (internal)

Secondary Publication Information
UI Title Author Country Year
Plasma n-3 polyunsaturated fatty acids in chronic heart failure in the GISSI-Heart Failure Trial: relation with fish intake, circulating biomarkers, and mortality. Masson S., Marchioli R., Mozaffarian D., Bernasconi R., Milani V., Dragani L., Tacconi M., Marfisi RM., Borgese L., Cirrincione V., Febo O., Nicolis E., Maggioni AP., Tognoni G., Tavazzi L., Latini R. Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy. 2013
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Effect of n-3 polyunsaturated fatty acids and rosuvastatin in patients with heart failure: results of the GISSI-HF trial. Marchioli R., Levantesi G., Silletta MG., Barlera S., Bernardinangeli M., Carbonieri E., Cosmi F., Franzosi MG., Latini R., Lucci D., Maggioni AP., Moretti L., Nicolosi GL., Porcu M., Rossi MG., Tognoni G., Tavazzi L. Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy. marchioli@negrisud.it 2009
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Effects of n-3 polyunsaturated fatty acids on malignant ventricular arrhythmias in patients with chronic heart failure and implantable cardioverter-defibrillators: A substudy of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca (GISSI-HF) trial. Finzi AA., Latini R., Barlera S., Rossi MG., Ruggeri A., Mezzani A., Favero C., Franzosi MG., Serra D., Lucci D., Bianchini F., Bernasconi R., Maggioni AP., Nicolosi G., Porcu M., Tognoni G., Tavazzi L., Marchioli R. Unit of Cardiovascular Medicine, Cardiopulmonary Dept, Fondazione Ca' Granda/Policlinico, Milano, Italy. 2011
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n-3 polyunsaturated fatty acids and atrial fibrillation in patients with chronic heart failure: the GISSI-HF trial. Aleksova A., Masson S., Maggioni AP., Lucci D., Fabbri G., Beretta L., Mos L., Paino AM., Nicolosi GL., Marchioli R., Tognoni G., Tavazzi L., Sinagra G., Latini R. Cardiovascular Department, 'Ospedali Riuniti' and University of Trieste, Trieste, Italy. 2013
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Effect of n-3 polyunsaturated fatty acids and rosuvastatin in patients with heart failure: results of the GISSI-HF trial. Marchioli R., Levantesi G., Silletta MG., Barlera S., Bernardinangeli M., Carbonieri E., Cosmi F., Franzosi MG., Latini R., Lucci D., Maggioni AP., Moretti L., Nicolosi GL., Porcu M., Rossi MG., Tognoni G., Tavazzi L. Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy. marchioli@negrisud.it 2009
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) n-3 PUFA
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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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What is the name of this study? (e.g. DART, Physician's Health Study) GISSI-HF
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Country in which study conducted (where subjects live) Italy
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Funding source Industry funded
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Eligibility Criteria: Eligible patients were men and women aged 18 years or older, with clinical evidence of heart failure of any cause that was classifi ed according to the European Society of Cardiology (ESC) guidelines as New York Heart Association (NYHA) class II–IV, provided that they had had their LVEF measured within 3 months before enrolment. When LVEF was greater than 40%, the patient had to have been admitted at least once to hospital for heart failure in the preceding year to meet the inclusion criteria. Major exclusion criteria included specifi c indication or contraindication to n-3 PUFA; known hypersensi tivity to study treatments; presence of any non-cardiac comorbidity (eg, cancer) that was unlikely to be compatible with a suffi ciently long follow-up; treatment with any investigational agent within 1 month before randomisation; acute coronary syndrome or revascularisation procedure within the preceding 1 month; planned cardiac surgery, expected to be done within 3 months after randomisation; signifi cant liver disease; and pregnant or lactating women or women of childbearing potential who were not adequately protected against becoming pregnant.
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 3.9 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... symptomatic heart failure of any cause and with any level of left ventricular ejection fraction (LVEF).
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... subgroups of patients defined according to age (above vs below the median value); left ventricular function (LVEF >40% vs ≤40%); cause of heart failure (ischaemic vs non-ischaemic); functional capacity (NYHA class II vs III or IV); presence of diabetes (yes vs no); and baseline total cholesterol concentrations (above vs below the median value).
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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) 2002
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 28.4 28.2
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41.8 41.6
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CABG 17.6; PCI 12.2 CABG 18.9; PCI 12.7
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50 47.1
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Admission for HF in the previous year Admission for HF in the previous year
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4.8 5.1
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8.4 9.1
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7.1 7.2
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implantable cardiac defibrillators implantable cardiac defibrillators
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Baseline characteristics, continuous 67 67
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11 11
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126 126
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18 18
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77 77
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10 10
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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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mmol/L nd
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1.42 27
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IQR (1.05, 1.98) 5
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27
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5
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Male, percent 77.8 78.8
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Race nd
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Comments about baseline data No data entered.
Baseline diet description nd
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Baseline omega-3 intake nd
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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: 45770
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 955 1014
Percentage 27.3 29.1
Outcome: Death      Population: 45770
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 74 70
Percentage 26.6 24.3
Outcome: Death      Population: 45771
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 50 44
Percentage 1.4 1.3
Outcome: death      Population: 45772
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 712 765
Percentage 20.4 22.0
Outcome: death      Population: 45772
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 42 45
Percentage 15.1 15.6
Outcome: arrhythmia      Population: 45773
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 307 325
Percentage 8.8 9.3
Outcome: arrhythmia      Population: 45773
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 10 6
Percentage 3.6 2.1
Outcome: cardiac      Population: 45774
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 107 129
Percentage 3.1 3.7
Outcome: cerebro      Population: 45775
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 122 103
Percentage 3.5 3.0
Outcome: arrhythmia      Population: 45781
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 76 98
Percentage 27.3 34.0
Outcome: arrhythmia      Population: 46172
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 2921 2914
Counts 444 408
Percentage 15.2 14
Outcome: arrhythmia      Population: 46172
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 2492 2499
Counts 278 244
Percentage 11.6 9.8
Outcome: arrhythmia      Population: 46172
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 2199 2242
Counts 241 202
Percentage 11.0 9.0
Outcome: arrhythmia      Population: 46173
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 61 82
Percentage 22 28.5
Outcome: arrhythmia      Population: 46174
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 278 288
Counts 34 37
Percentage 12.2 12.9
Outcome: arrhythmia      Population: 46175
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled
Counts
Percentage
Outcome: composite      Population: 51514
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Enrolled 3494 3481
Counts 1981 2053
Percentage 57 59
Outcome: bp      Population: 45776
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Analyzed 3494 3481
Outcome: bp      Population: 45777
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Analyzed 3494 3481
Outcome: lipid      Population: 45778
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 3494 3481
Median 1.42 nd
25th Percentile 1.05 nd
75th Percentile 1.98 nd


1 years

N Analyzed 3494 3481
Median 1.36 nd
25th Percentile 0.99 nd
75th Percentile 1.93 nd


3 years

N Analyzed 3494 3481
Median 1.34 nd
25th Percentile 0.98 nd
75th Percentile 1.85 nd
Outcome: lipid      Population: 45779
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Analyzed 3494 3481
Outcome: lipid      Population: 45780
Time Point Measure "Fish oil" (DHA+EPA) Placebo


3.9 years

N Analyzed 3494 3481

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Gastrointestinal disorder 96 3494 3.9 years
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Placebo 92 3481 3.9 years
"Fish oil" (DHA+EPA) Allergic reaction 3 3494 3.9 years
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Placebo 9 3481 3.9 years
"Fish oil" (DHA+EPA) Liver dysfunction 1 3494 3.9 years
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Placebo 1 3481 3.9 years
"Fish oil" (DHA+EPA) Lipid abnormality 0 3494 3.9 years
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Placebo 1 3481 3.9 years
"Fish oil" (DHA+EPA) Hepatocellular jaundice 0 3494 3.9 years
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Placebo 1 3481 3.9 years
"Fish oil" (DHA+EPA) Subdural haematoma 1 3494 3.9 years
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Placebo 0 3481 3.9 years
"Fish oil" (DHA+EPA) Muscle-related symptoms 1 3494 3.9 years
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Placebo 0 3481 3.9 years
"Fish oil" (DHA+EPA) Patients permanently discontinuing study treatment due to serious ADR 1 3494 3.9 years
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Placebo 0 3481 3.9 years

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)? HIGH partial results for BP, lipids, statin interactions reported
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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? HIGH 71.6% were 80% compliant
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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.