Evidence map›Paper›PMID 18757090›Full record

Trial reportLancet (London, England)2008

Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.

Luigi Tavazzi, Aldo P Maggioni, Roberto Marchioli, Simona Barlera, Maria Grazia Franzosi, Roberto Latini, Donata Lucci, Gian Luigi Nicolosi, Maurizio Porcu, Gianni Tognoni and 1 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00336336. Cited by 451 papers, 31 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
451citing papers in PubMed, 31 pooled it
73.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00336336 phase3completed

A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure

Ran2002Enrolled6,975Registered outcomes10Posted comparisons0ConditionsHeart FailureArmsn-3 PUFA, Placebo, Rosuvastatin
PMID 18757089PMID 15302013other papers from this trial
Open the trial in the graph
NCT02349555 nacompletednot on this mapstarted 2015, after this paper: background citation

An Open-Label Single-Center Study to Determine Safety and Effects of Novel Nutritional Blend on Inflammatory Balance Markers and Metabolic Parameters

TypeinterventionalSponsorPharmanexRan2015 to 2016Enrolled41ConditionsOther Endocrine/Nutritional/Metabolic DisorderArmsNutritional Supplement Blend
3 · Its place in the literature

Who cites it

451 citing papers in PubMed, 31 syntheses or guidelines pooled it, 1,345 citations in OpenAlex.

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  13. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
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  14. Omega-3 for the prevention of cardiovascular diseases: meta-analysis and trial-sequential analysis.European journal of hospital pharmacy : science and practice · 2022
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  20. Omega-3 Polyunsaturated Fatty Acids and Stroke Burden.International journal of molecular sciences · 2019
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391 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Luigi Tavazzi
Aldo P Maggioni
Roberto Marchioli
Simona Barlera
Maria Grazia Franzosi
Roberto Latini
Donata Lucci
Gian Luigi Nicolosi
Maurizio Porcu
Gianni Tognoni
Gissi-HF Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral epidemiological and experimental studies suggest that n-3 polyunsaturated fatty acids (PUFA) can exert favourable effects on atherothrombotic cardiovascular disease, including arrhythmias. We investigated whether n-3 PUFA could improve morbidity and mortality in a large population of patients with symptomatic heart failure of any cause.

methodsWe undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy. We enrolled patients with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (n=3494) or placebo (n=3481) by a concealed, computerised telephone randomisation system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.5). Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00336336.

findingsWe analysed all randomised patients. 955 (27%) patients died from any cause in the n-3 PUFA group and 1014 (29%) in the placebo group (adjusted hazard ratio [HR] 0.91 [95.5% CI 0.833-0.998], p=0.041). 1981 (57%) patients in the n-3 PUFA group and 2053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 0.92 [99% CI 0.849-0.999], p=0.009). In absolute terms, 56 patients needed to be treated for a median duration of 3.9 years to avoid one death or 44 to avoid one event like death or admission to hospital for cardiovascular reasons. In both groups, gastrointestinal disorders were the most frequent adverse reaction (96 [3%] n-3 PUFA group vs 92 [3%] placebo group).

interpretationA simple and safe treatment with n-3 PUFA can provide a small beneficial advantage in terms of mortality and admission to hospital for cardiovascular reasons in patients with heart failure in a context of usual care.

Indexed as

AgedChronic DiseaseDouble-Blind MethodEndpoint DeterminationFatty Acids, Omega-3FemaleFollow-Up StudiesHeart FailureHospitalizationHumansItalyMaleVentricular Function, LeftFatty Acids, Omega-3

Identifiers

PMID18757090
OpenAlexW2167075471

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.