Evidence map›Paper›PMID 15302013›Full record

Trial reportEuropean journal of heart failure2004

Rationale and design of the GISSI heart failure trial: a large trial to assess the effects of n-3 polyunsaturated fatty acids and rosuvastatin in symptomatic congestive heart failure.

Luigi Tavazzi, Gianni Tognoni, Maria Grazia Franzosi, Roberto Latini, Aldo Pietro Maggioni, Roberto Marchioli, Gian Luigi Nicolosi, Maurizio Porcu, GISSI-HF Investigators

2 registry-linked trialsAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of heart failure, 2004. 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 39 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 11 pooled it
17.4field-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 18757090other papers from this trial
Open the trial in the graph
NCT00795912 phase4completed

A Study Of The Usage Of Statins In A Community Heart Failure Population: The Impact of HMG Co-Enzyme A Reductase Inhibitors on Heart Structural Parameters, Brain Naturetic Peptide, Markers of Inflammation and Fibrosis

Ran2003Enrolled56Registered outcomes2Posted comparisons0ConditionsHeart FailureArmsAtorvastatin
PMID 11555537PMID 12020481PMID 11996626PMID 11036910PMID 15926863PMID 15313958PMID 14726474PMID 12034159PMID 12009719PMID 11806812PMID 11094035PMID 9922372other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 11 syntheses or guidelines pooled it, 239 citations in OpenAlex.

  1. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
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  5. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2019
    Pooled it
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  12. Trial
  13. Should patients perception of health status be integrated in the prognostic assessment of heart failure patients? A prospective study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014
    Trial
  14. Trial
  15. Review
  16. New Targets in Heart Failure Drug Therapy.Frontiers in cardiovascular medicine · 2021
    Review
  17. Review
  18. Article
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  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Luigi TavazziPoliclinico San Matteo, IRCCS, Pavia, Italy.
Gianni Tognoni
Maria Grazia Franzosi
Roberto Latini
Aldo Pietro Maggioni
Roberto Marchioli
Gian Luigi Nicolosi
Maurizio Porcu
GISSI-HF Investigators
Mario Negri Institute for Pharmacological Research · ITMario Negri Sud Foundation · ITAssociazione Nazionale Medici Cardiologi Ospedalieri · ITAzienda Ospedaliera G. Brotzu · ITAzienda Ospedaliera Santa Maria Degli Angeli · ITPoliclinico San Matteo Fondazione · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe GISSI Heart Failure project is a large-scale, randomized, double-blind study designed to investigate the effects of n-3 polyunsaturated fatty acids and rosuvastatin on mortality and morbidity in patients with symptomatic heart failure. METHODS AND

resultsPatients with New York Heart Association classes II to IV heart failure, already receiving optimized recommended therapy, will be recruited in a nation-wide network of more than 300 cardiology and internal medicine services to be randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily) or the corresponding placebo. Patients with no clear indication or contraindication to cholesterol-lowering therapy will be further randomized to receive low-dose rosuvastatin (10 mg daily) or placebo. According to data available in heart failure registries, it is expected that 70% of the patients will be suitable to enter both components of the trial, which assume the same co-primary endpoints: (a) 15% reduction of all-cause mortality and (b) 20% reduction of all-cause mortality or cardiovascular hospitalizations. The trial is event-driven and will continue either until at least 1252 deaths have been recorded or a reduction of all-cause mortality will satisfy the significance boundaries, which have been established to stop the study. The recruitment of the planned sample size of approximately 7000 patients randomized in the n-3 PUFA trial is expected to be completed within 18 months from the trial start. As of February 29, 2004, 4624 heart failure patients have been included in the trial.

conclusionThe GISSI-HF project, with its protocol articulated into two independent randomization schemes, has the aim and the power to verify the hypothesis that n-3 polyunsaturated fatty acids and rosuvastatin can favorably modify the prognosis of patients with symptomatic heart failure.

Indexed as

Fatty Acids, Omega-3Fatty Acids, UnsaturatedFluorobenzenesHeart FailureHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsPyrimidinesRandomized Controlled Trials as TopicResearch DesignRosuvastatin CalciumSulfonamidesTriglyceridesFatty Acids, Omega-3Fatty Acids, UnsaturatedFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsPikasolPyrimidinesRosuvastatin CalciumSulfonamidesTriglycerides

Identifiers

PMID15302013
OpenAlexW2088451948

What OpenQuestion holds

Texttitle and abstract
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 OpenQuestion graph.