AzTrials
AzTrials

Heart FailurePhase 3NCT00336336

GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF

A Phase 3 study testing n-3 PUFA and Rosuvastatin in people with Heart Failure, run by Gruppo di Ricerca GISSI at 337 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
n-3 PUFA and Rosuvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,975 participants
Where
337 sitesin 2 countries
Study dates
Aug 2002to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
  • Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% >40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
  • No age limits
  • Any etiology
  • Informed consent (obtained before any study specific procedure)

Who cannot join

  • COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):
  • Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
  • planned cardiac surgery, expected to be performed within 3 months;
  • congenital or primary valvular etiology;
  • known hypersensitivity to study treatments;
  • significant liver disease;
Show all 14Show fewer
  • pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
  • any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
  • presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
  • treatment with any investigational agent within 1 month before randomization;
  • patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.
  • current serum creatinine level >2.5 mg/dL;
  • current ALT, AST level >1.5 times the upper normal limit;
  • current CPK upper normal limits.

Trial locations and contacts

337 sites in 2 countries.

301 sites in 2 countries

Italy300 sites

  • Ospedale Civile

    Acqui Terme, AL, 15011

  • Ospedale Civile

    Adria, RO, 45011

  • Ospedale Civile

    Agordo, BL, 32021

  • Ospedale San Giovanni di Dio

    Agrigento, AG, 92100

  • Ospedale Civile San Lazzaro

    Alba, CN, 12051

  • Ospedali Riuniti Albano-Genzano

    Albano Laziale, RM, 00041

  • Presidio Cardiologico G.M. Lancisi

    Ancona, AN, 60122

  • Ospedale Generale Regionale

    Aosta, AO, 11100

  • Ospedale Alto Garda e Ledro

    Arco, TN, 38062

  • Ospedale San Donato

    Arezzo, AR, 52100

  • Osp. Gen.le Prov.le C.G.Mazzoni

    Ascoli Piceno, AP, 63100

  • Ospedale Cardinal Massaia

    Asti, AT, 14100

  • Presidio Ospedaliero Moscati

    Aversa, CE, 81031

  • Ospedale Civile SS.Filippo e Nicola

    Avezzano, AQ, 67051

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli, FI, 50011

  • Nuovo Pres.Osp. Cutroni Zodda

    Barcellona Pozzo di Gotto, ME, 98050

  • Ospedale San Paolo

    Bari, BA, 70123

  • Ospedale Consorziale Policlinico

    Bari, BA, 70124

  • Ospedale di Venere

    Bari - Carbonara, BA, 70012

  • Ospedale Monsignor Angelo R. di Miccoli

    Barletta, BA, 70051

  • Presidio Ospedaliero S.Maria della Speranza

    Battipaglia, SA, 84091

  • Ospedale Dossetti

    Bazzano, BO, 40053

  • Ospedale Civile

    Belluno, BL, 32100

  • Ospedale di Bentivoglio

    Bentivoglio, BO, 40010

  • Ospedali Riuniti di Bergamo

    Bergamo, BG, 24128

  • Ospedale Policlinico S.Orsola-M.Malpighi

    Bologna, BO, 40138

  • Ospedale Bellaria

    Bologna, BO, 40139

  • Presidio Ospedaliero del Mugello

    Borgo San Lorenzo, FI, 50032

  • Ospedale SS. Trinita'

    Borgomanero, 28021

  • Ospedale Civile di Boscotrecase

    Boscotrecase, 80042

  • Ospedale Civile San Biagio

    Bovolone, VR, 37051

  • Spedali Civili

    Brescia, BS, 25123

  • Osedale A. Businco

    Cagliari, CA, 09121

  • Presidio Ospedaliero SS. Trinita'

    Cagliari, CA, 09121

  • Ospedale Marino

    Cagliari, CA, 09126

  • Azienda Osped. G.Brotzu-S.Michele (S.S.D.coord.Scompenso)

    Cagliari, CA, 09134

  • Azienda Ospedaliera G. Brotzu - S. Michele

    Cagliari, CA, 09134

  • Universita'

    Cagliari-Monserrato, CA, 09042

  • Ospedale Generale Provinciale Gravina

    Caltagirone, CT, 95041

  • Ospedale Santa Maria della Pieta'

    Camerino, MC, 62032

  • Ospedale di Camposampiero

    Camposampiero, PD, 35012

  • Ospedale Barone Lombardo

    Canicattì, AG, 92024

  • Ospedale V. Cosentino

    Cariati, CS, 87063

  • Civico Ospedale Carrara

    Carrara, MS, 54033

  • Ospedale Civile Oglio Po

    Casalmaggiore, CR, 26041

  • Presidio Ospedaliero F. Ferrari

    Casarano, LE, 73042

  • Az. Ospedaliera S.Anna e S.Sebastiano

    Caserta, CE, 81100

  • Azienda Ospedaliera Sant'Anna e San Sebastiano

    Caserta, CE, 81100

  • Fondazione S. Maugeri Clinica del Lavoro

    Cassano delle Murge, BA, 70020

  • Ospedale Santa Scolastica

    Cassino, FR, 03043

  • Opsedale San Leonardo

    Castellammare di Stabia, 80053

  • IRCCS Saverio De Bellis

    Castellana Grotte, BA, 70013

  • Ospedale Civile

    Castellaneta, TA, 74011

  • Ospedale Sant'Anna

    Castelnovo ne' Monti, Re, 42035

  • Ospedale Santa Croce

    Castelnuovo Garfagnana, LU, 55032

  • Ospedale Civile Vittorio Emanuele II

    Castelvetrano, TP, 91022

  • Ospedale San Pellegrino

    Castiglione delle Stiviere, MN, 46043

  • Ospedale Civile Ferrari

    Castrovillari, CS, 87012

  • Ospedale Garibaldi - Nesima

    Catania, CT, 95122

  • Ospedale Garibaldi-Nesima

    Catania, CT, 95122

  • Ospedale Ferrarotto

    Catania, CT, 95124

  • Ospedale Garibaldi - Centro

    Catania, CT, 95124

  • Ospedale Vittorio Emanuele II

    Catania, CT, 95124

  • Ospedale Cannizzaro (U.O.Cardiologia)

    Catania, CT, 95126

  • Ospedle Cannizzaro (UTIC)

    Catania, CT, 95126

  • Azienda Ospedaliera Mater Domini

    Catanzaro, CZ, 88100

  • Ospedale Civile Pugliese

    Catanzaro, CZ, 88100

  • Ospedale Civile Bassa Val di Cecina

    Cecina, LI, 57023

  • Fondazione San Raffaele G. Giglio

    Cefalù, PA, 90015

  • Ospedale Civile Giuseppe Tatarella

    Cerignola, FG, 71042

  • Ospedale di Cernusco sul Naviglio

    Cernusco sul Naviglio, MI, 20063

  • Ospedale M. Bufalini-G. Marconi

    Cesena, FC, 47023

  • Ospedale M.Bufalini-G.Marconi

    Cesenatico, FC, 47042

  • Ospedale Civile Mellini

    Chiari, BS, 25032

  • Ospedale Alta Valle del Tevere

    Città di Castello, PG, 06012

  • Ospedale di Cittadella

    Cittadella, PD, 35013

  • Ospedale Civile San Paolo

    Civitavecchia, RM, 00053

  • Ospedale Generale Zona Parodi Delfino

    Colleferro, RM, 00034

  • Ospedale Generale di Zona Valduce

    Como, CO, 22100

  • Ospedale S. Anna

    Como, CO, 22100

  • Ospedale De Gironcoli

    Conegliano Veneto, TV, 31015

  • Ospedale Santa Maria dei Battuti

    Conegliano Veneto, TV, 31015

  • Ospedale Civile Guido Compagna

    Corigliano Calabro, CS, 87064

  • Ospedale Civile San Sebastiano

    Correggio, RE, 42015

  • Ospedale Valdichiana Santa Margherita

    Cortona, AR, 52040

  • INRCA Istituto Cardiovasculop.Senili

    Cosenza, CS, 87100

  • Ospedale Santissima Annunziata

    Cosenza, CS, 87100

  • Presidio Ospedaliero Mariano Santo

    Cosenza, CS, 87100

  • Villa Maria Cecilia Hospital

    Cotignola, RA, 48010

  • Istituti Ospitalieri di Cremona

    Cremona, CR, 26100

  • Ospedale Civile San Giovanni di Dio

    Crotone, KR, 88900

  • Azienda Ospedaliera

    Desenzano del Garda, BS, 25015

  • Ospedale Civile

    Dolo, VE, 30031

  • Ospedale Civile San Giuseppe

    Empoli, FI, 50053

  • Ospedale Civile Sant'Antonio Abate

    Erice, TP, 91016

  • Ospedale Generale Provinciale

    Este, PD, 35042

  • Ospedale Umberto I

    Fasano, BR, 72015

  • Ospedale Civile Augusto Murri

    Fermo, AP, 63023

  • Arcispedale Sant'Anna

    Ferrara, FE, 44100

  • Ospedale Civile

    Fidenza, PR, 43036

  • Ospedale Santa Maria Nuova

    Florence, FI, 50122

  • Presidio Ospedaliero di Camerata

    Florence, FI, 50133

  • Az. Ospedaliero-Universitaria Careggi

    Florence, FI, 50134

  • Az. Ospedaliero-Universitaria Careggi

    Florence, FI, 50139

  • Az. Ospedaliero-Universitaria Careggi

    Florence, FI, 50141

  • Nuovo Ospedale San Giovanni di Dio

    Florence, FI, 50143

  • Ospedali Riuniti

    Foggia, FG, 71100

  • Nuovo Ospedale San Giovanni Battista

    Foligno, PG, 06034

  • Ospedale G.B.Morgagni-L.Pierantoni

    Forlì, FC, 47100

  • Ospedale del dono Svizzero

    Formia, LT, 04023

  • Ospedale Maggiore SS. Trinita'

    Fossano, CN, 12045

  • Ospedale Civile Dario Camberlingo

    Francavilla Fontana, BR, 72021

  • Ospedale San Sebastiano Martire

    Frascati, RM, 00044

  • Ospedale Civile San Giovanni di Dio

    Frattaminore, 80027

  • Ospedale San Pietro Igneo

    Fucecchio, FI, 50054

  • Ospedale Civile

    Gaeta, LT, 04024

  • Ospedale Santa Caterina Novella

    Galatina, LE, 73013

  • Ospedale S. Antonio Abate

    Gallarate, VA, 21013

  • Ospedale Civile Sacro Cuore di Gesu'

    Gallipoli, LE, 73014

  • Presidio Ospedaliero

    Gavardo, BS, 25085

  • Dimi-Disem

    Genova, GE, 16132

  • Ospedali Civili di Sampierdarena

    Genova-Sampierdarena, GE, 16149

  • Ospedale Padre Antero Micone

    Genova-Sestri Ponente, GE, 16153

  • Ospedale Generale di Zona

    Giugliano in Campania, 80014

  • Ospedale Carlo Borella

    Giussano, MI, 20034

  • Presidio Ospedaliero di Gorizia

    Gorizia, GO, 34170

  • Ospedale della Misericordia

    Grosseto, GR, 58100

  • Ospedale Gubbio-Gualdo Tadino

    Gubbio, PG, 06024

  • Ospedale F. Veneziale

    Isernia, IS, 86170

  • Presidio Ospedaliero San Salvatore

    L’Aquila, AQ, 67100

  • Ospedale S. Andrea

    La Spezia, SP, 19124

  • Ospedale Generale di Zona

    Lagonegro, PZ, 85042

  • Ospedale del Delta

    Lagosanto, FE, 44023

  • Ospedale Renzetti

    Lanciano, CH, 66034

  • Ospedale Civile G. Vietri

    Larino, CB, 86035

  • Ospedale S. Maria Goretti

    Latina, LT, 04100

  • Ospedale Vito Fazzi

    Lecce, LE, 73100

  • Ospedale Umberto I

    Lecco, LC, 23900

  • Ospedale Mater Salutis

    Legnago, VR, 37045

  • Ospedale Civile

    Legnano, MI, 20025

  • Ospedale San Giacomo D'Altopasso

    Licata, AG, 92027

  • Nuovo Ospedale Versilia

    Lido di Camaiore, LU, 55043

  • Ospedali Riuniti

    Livorno, LI, 57124

  • Azienda Ospedaliera Mater Domini

    Località Germaneto - Catanzaro, CZ, 88100

  • Ospedale Civile Simiani

    Loiano, BO, 40050

  • Ospedale di Manerbio

    Manerbio, BS, 25025

  • Ospedale San Camillo De Lellis

    Manfredonia, FG, 71043

  • Presidio Ospedaliero C. Poma

    Mantua, MN, 46100

  • P.O. Marcianese ASL Caserta 1

    Marcianise, CE, 81025

  • A.O. S. Anna-Presidio di Mariano Comense

    Mariano Comense, Co, 22066

  • Ospedale San Giuseppe

    Marino, RM, 00047

  • Presidio Ospedaliero della Valle D'Itria

    Martina Franca, TA, 74015

  • IFC CNR-Ospedale Pasquinucci

    Massa, MS, 54100

  • Ospedale SS.Giacomo e Cristoforo

    Massa, MS, 54100

  • Ospedale S.Andrea-Alta Maremma

    Massa Marittima, GR, 58024

  • Ospedale Madonna delle Grazie

    Matera, MT, 75100

  • Ospedale A. Ajello

    Mazara del Vallo, TP, 91026

  • Ospedale San Martino

    Mede, PV, 27035

  • Ospedale di Menaggio

    Menaggio, CO, 22017

  • Ospedale Generale Provinciale

    Merano, BZ, 39012

  • Ospedale G. Fucito

    Mercato San Severino, SA, 84085

  • Ospedale di Mesoraca

    Mesoraca, KR, 88838

  • Ospedale Papardo

    Messina, ME, 98158

  • Ospedale Civile Umberto I

    Mestre, VE, 30171

  • Ospedale Fatebenefratelli

    Milan, MI, 20121

  • Ospedale Maggiore Policlinico

    Milan, MI, 20122

  • Centro Cardiologico Monzino

    Milan, MI, 20138

  • Ospedale San Paolo

    Milan, MI, 20142

  • Ospedale San Carlo Borromeo

    Milan, MI, 20153

  • Ospedale Niguarda-Villa Marelli

    Milan, MI, 20159

  • Ospedale Niguarda

    Milan, MI, 20162

  • MIOspedale San Raffaele

    Milan, 20132

  • Ospedale Civile

    Milazzo, ME, 98057

  • Ospedale Generale di Zona

    Minturno, LT, 04026

  • Ospedale Civile

    Mirano, VE, 30035

  • Ospedale Policlinico

    Modena, MO, 41100

  • Ospedale Santa Croce

    Moncalieri, To, 10024

  • Presidio Ospedaliero Valdichiana Senese

    Montepulciano, SI, 53045

  • Ospedale di Monterotondo

    Monterotondo, RM, 00015

  • Fondazione S.Maugeri Clinica del Lavoro

    Montescano, PV, 27040

  • Osp.Valdarno "S.Maria della Gruccia"

    Montevarchi, AR, 52027

  • Ospedale San Gerardo

    Monza, MI, 20052

  • Policlinico di Monza

    Monza, MI, 20052

  • Ospedale Civile

    Morbegno, SO, 23017

  • Ospedale Civile Minervini

    Mormanno, CS, 87026

  • Ospedale Umberto I

    Mottola, TA, 74017

  • AORN Cardarelli

    Naples, 80131

  • Azienda Ospedaliera Vincenzo Monaldi

    Naples, 80131

  • Fondazione Pascale

    Naples, 80131

  • Ospedale Domenico Cotugno

    Naples, 80131

  • Policlinico Universitario Federico II

    Naples, 80131

  • Ospedale Sacro Cuore

    Negrar, VR, 37024

  • Ospedale G. Basilotta

    Nicosia, EN, 94014

  • Ospedale Civile

    Nocera Inferiore, SA, 84014

  • Pres.Ospedaliero S. Maria della Pieta'

    Nola, 80035

  • Ospedale Civile

    Noventa Vicentina, VI, 36025

  • Ospedale San Giacomo

    Novi Ligure, AL, 15067

  • Ospedale San Francesco

    Nuoro, NU, 08100

  • Ospedale San Francesco D'Assisi

    Oliveto Citra, SA, 84020

  • Ospedale San Luigi Gonzaga

    Orbassano, TO, 10043

  • Ospedale San Giovanni di Dio

    Orbetello, GR, 58015

  • Ospedale Buccheri La Ferla Fatebenefratelli

    Palermo, PA, 90123

  • A.R.N.A.S. Ospedale Civico e Benfratelli

    Palermo, PA, 90127

  • Ospedale G.F. Ingrassia

    Palermo, PA, 90129

  • Ospedale G.F. Ingrassia

    Palermo, PA, 90132

  • Az. Osp. Villa Sofia CTO (Cardiologia II)

    Palermo, PA, 90146

  • Ospedale V. Cervello

    Palermo, PA, 90146

  • Presidio Ospedaliero Villa Sofia

    Palermo, PA, 90146

  • Ospedale di Ialmicco - Palmanova - Udine

    Palmanova, UD, 33057

  • Ospedale San Francesco di Paola

    Paola, CS, 87027

  • Az. Ospedaliera Universitaria di Parma

    Parma, PR, 43100

  • Centro Osp.Riabilit.Intensiva (CORI)

    Passignano sul Trasimeno, PG, 06065

  • Presidio Ospedaliero di Passirana

    Passirana-Rho, MI, 20017

  • Ospedale Barone Romeo

    Patti, ME, 98066

  • IRCCS - Fondazione Salvatore Maugeri

    Pavia, PV, 27100

  • Ospedale Policlinico San Matteo IRCCS

    Pavia, PV, 27100

  • Presidio Ospedaliero

    Pavullo nel Frignano, MO, 41026

  • Ospedale Civile San Massimo

    Penne, PE, 65017

  • Ospedale Civile dello Spirito Santo

    Pescara, PE, 65124

  • Ospedale M. Chiello

    Piazza Armerina, EN, 94015

  • Ospedale Civile Ave Gratia Plena

    Piedimonte Matese, CE, 81016

  • Ospedale Civile del Cadore

    Pieve di Cadore, BL, 32044

  • Ospedali Destra Secchia

    Pieve di Coriano, MN, 46020

  • Ospedale Civile E. Agnelli

    Pinerolo, TO, 10064

  • Ospedale Villamarina

    Piombino, LI, 57025

  • Presidio Ospedaliero

    Poggibonsi, SI, 53034

  • Ospedale Civile

    Policoro, MT, 75025

  • Azienda Ospedaliera S. Maria degli Angeli

    Pordenone, PN, 33170

  • Ospedale Civile

    Portogruaro, VE, 30026

  • Azienda Ospedaliera San Carlo

    Potenza, PZ, 85100

  • Ospedale Santa Maria delle Grazie

    Pozzuoli, 80078

  • Ospedale Misericordia e Dolce

    Prato, PO, 59100

  • Ospedale Generale Provinciale

    Province of Macerata, MC, 62100

  • Ospedale Santa Maria degli Angeli

    Putignano, BA, 70017

  • Ospedale Civile

    Ragusa, RG, 97100

  • Ospedale M.P. Arezzo

    Ragusa, RG, 97100

  • Policlinico Madonna della Consolazione

    Reggio Calabria, RC, 89124

  • Ospedale G. Ceccarini

    Riccione, RN, 47838

  • P.O. San Camillo De Lellis

    Rieti, RI, 02100

  • Ospedale Infermi

    Rimini, RN, 47900

  • Ospedale Santa Marta

    Rivolta d'Adda, CR, 26027

  • Ospedale Santa Barbara

    Rogliano, CS, 87054

  • Campus Biomedico

    Roma, RM, 00128

  • Ospedale San Filippo Neri

    Roma, RM, 00135

  • Ospedale Sant'Eugenio

    Roma, RM, 00144

  • Ospedale C. Forlanini

    Roma, RM, 00149

  • Ospedale San Camillo

    Roma, RM, 00149

  • Ospedale San Camillo

    Roma, RM, 00152

  • Ospedale Sandro Pertini

    Roma, RM, 00157

  • Policlinico Umberto Primo

    Roma, RM, 00161

  • Ospedale San Carlo di Nancy

    Roma, RM, 00165

  • Presidio Ospedaliero Villa Betania

    Roma, RM, 00165

  • Ospedale Generale di Zona "Cristo Re"

    Roma, RM, 00167

  • Ospedale Fatebenefratelli

    Roma, RM, 00168

  • Policlinico Agostino Gemelli

    Roma, RM, 00168

  • I.N.R.C.A.

    Roma, RM, 00189

  • Ospedale Santo Spirito

    Roma, RM, 00193

  • Ospedale Civile N. Giannettasio

    Rossano, CS, 87068

  • Presidio Ospedaliero

    Rovigo, RO, 45100

  • A.O. S.Giovanni di Dio e Ruggi di Aragona

    Salerno, SA, 84131

  • Ospedale Civile Saluzzo

    Saluzzo, CN, 12037

  • Ospedale Madonna del Soccorso

    San Benedetto del Tronto, AP, 63039

  • Ospedale G. Fra Castoro

    San Bonifacio, VR, 37047

  • Presidio Osped. Pneumologico Galateo

    San Cesario di Lecce, LE, 73016

  • Ospedale S. Antonio

    San Daniele del Friuli, UD, 33038

  • Ospedale Ave Gratia Plena

    San Felice A Cancello, CE, 81027

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

  • Ospedale N. Melli

    San Pietro Vernotico, BR, 72027

  • Ospedale Civile

    San Vito al Tagliamento, PN, 33078

  • Presidio Ospedaliero

    Sanremo, IM, 18038

  • P.O. Sant'Agata di Militello

    Sant'Agata di Militello, ME, 98076

  • Ospedale dell'Immacolata

    Sapri, SA, 84073

  • Presidio Ospedaliero

    Saronno, VA, 21047

  • Ospedale San Bartolomeo

    Sarzana - Loc. Santa Caterina, SP, 19038

  • Az. Ospedaliero Universitaria di Sassari

    Sassari, SS, 07100

  • Nuovo Ospedale Civile di Sassuolo

    Sassuolo, MO, 41049

  • Ospedale Civile

    Scafati, SA, 84018

  • Ospedale Scillesi D'America

    Scilla, RC, 89024

  • Ospedale Scillesi D'America

    Scilla, RC, 89058

  • Ospedale Ignazio Veris Delli Ponti

    Scorrano, LE, 73020

  • Ospedale Bolognini

    Seriate, BG, 24068

  • Presidio Gazzaniga c/o Osp. Seriate

    Seriate, BG, 24068

  • Ospedale di Sesto San Giovanni

    Sesto San Giovanni, MI, 20099

  • Ospedale Sestri Levante

    Sestri Levante, GE, 16039

  • Policlinico Santa Maria alle Scotte

    Siena, SI, 53100

  • Ospedale di Circolo A. Bellini

    Somma Lombardo, VA, 21019

  • Ospedale E. Morelli

    Sondalo, SO, 23035

  • Ospedale Civile

    Sondrio, SO, 23100

  • Ospedale Civile SS. Trinita'

    Sora, FR, 03039

  • Presidio Ospedaliero

    Soriano Calabro, VV, 89831

  • Ospedale Santa Maria della Misericordia

    Sorrento, 80067

  • Ospedale A. Angelucci

    Subiaco, RM, 00028

  • Presidio Ospedaliero

    Susa, TO, 10059

  • Azienda Ospedaliera Umberto I

    Syracuse, SR, 96100

  • Presidio Ospedaliero San Vincenzo

    Taormina, ME, 98039

  • Ospedale S. Giuseppe Moscati

    Taranto, TA, 74100

  • Ospedale SS. Annunziata

    Taranto, TA, 74100

  • Ospedale Civile G. Mazzini

    Teramo, TE, 64100

  • Ospedale Pubblico S. Cimino

    Termini Imerese, PA, 90018

  • Ospedale San Timoteo

    Termoli, CB, 86039

Other trials in Italy

Switzerland1 site

  • Cardiocentro Ticino

    Lugano, 69000

Other trials in Switzerland

About this study

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

INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure.

STUDY DESIGN

Read more

The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to:

Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo.

OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES

To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:

  • All-cause mortality
  • All-cause mortality or hospitalizations for cardiovascular reason

OTHER END-POINT MEASURES OF EFFICACY

To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:

  • Cardiovascular mortality
  • Cardiovascular mortality or hospitalizations for any reason
  • Sudden cardiac death
  • Hospitalizations for any reason
  • Hospitalizations for cardiovascular reasons
  • Hospitalizations for congestive heart failure
  • Myocardial infarction
  • Stroke
Read the detailed description

The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer

Conditions
Heart Failure
Being tested
n-3 PUFA, Rosuvastatin, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • n-3 PUFADrug

    1 g die per os

  • RosuvastatinDrug

    10 mg die per os

  • PlaceboDrug

    1 gram c. per os

  • PlaceboDrug

    10 mg c. per os

Study groups in NCT00336336
Study groupRoleWhat they receive
1ExperimentalN-3PUFA
Receives: Drug: n-3 PUFA
2Placebo comparatorNot described
Receives: Drug: Placebo
3ExperimentalRosuvastatin
Receives: Drug: Rosuvastatin
4Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: from enrollment to 1252 deaths in R2 arm

  2. All cause mortality or hospitalizations for any reason

    Measured: from enrollment to 1252 deaths

Secondary outcomes (8)

  1. Cardiovascular mortality

    Measured: from enrollment to 1252 deaths in R2 arm

  2. Cardiovascular mortality or hospitalization for heart failure or for any reasons

    Measured: from enrollment to 1252 deaths in R2 arm

  3. Sudden cardiac death

    Measured: from enrollment to 1252 deaths in R2 arm

  4. Hospitalizations for any reasons

    Measured: from enrollment to 1252 deaths in R2 arm

  5. Hospitalization for Cardiovascular reasons

    Measured: from enrollment to 1252 deaths in R2 arm

  6. Hospitalization for congestive heart failure

    Measured: from enrollment to 1252 deaths in R2 arm

  7. Miocardial infarction

    Measured: from enrollment to 1252 deaths in R2 arm

  8. Stroke

    Measured: from enrollment to 1252 deaths in R2 arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2006 (estimated)
  2. Study startAug 2002
  3. Primary completionApr 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336336
Sponsor's protocol ID
G105
Status last verified
Sep 2010
First submitted
12 Jun 2006
Last updated
14 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Tavazzi L, Tognoni G, Franzosi MG, Latini R, Maggioni AP, Marchioli R, Nicolosi GL, Porcu M; GISSI-HF Investigators. 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. Eur J Heart Fail. 2004 Aug;6(5):635-41. doi: 10.1016/j.ejheart.2004.03.001.

    PubMed 15302013

  • Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1223-30. doi: 10.1016/S0140-6736(08)61239-8. Epub 2008 Aug 29.

    PubMed 18757090

  • Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1231-9. doi: 10.1016/S0140-6736(08)61240-4. Epub 2008 Aug 29.

    PubMed 18757089

  • Canepa M, Ameri P, Lucci D, Nicolosi GL, Marchioli R, Porcu M, Tognoni G, Franzosi MG, Latini R, Maseri A, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Modes of death and prognostic outliers in chronic heart failure. Am Heart J. 2019 Feb;208:100-109. doi: 10.1016/j.ahj.2018.11.009. Epub 2018 Nov 24.

    PubMed 30580128

  • Mantovani A, Targher G, Temporelli PL, Lucci D, Gonzini L, Nicolosi GL, Marchioli R, Tognoni G, Latini R, Cosmi F, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Prognostic impact of elevated serum uric acid levels on long-term outcomes in patients with chronic heart failure: A post-hoc analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) trial. Metabolism. 2018 Jun;83:205-215. doi: 10.1016/j.metabol.2018.02.007. Epub 2018 Mar 29.

    PubMed 29477817

  • Dauriz M, Targher G, Temporelli PL, Lucci D, Gonzini L, Nicolosi GL, Marchioli R, Tognoni G, Latini R, Cosmi F, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial. J Am Heart Assoc. 2017 Jul 5;6(7):e005156. doi: 10.1161/JAHA.116.005156.

    PubMed 28679559

  • Rossi A, Inciardi RM, Rossi A, Temporelli PL, Lucci D, Gonzini L, Marchioli R, Nicolosi GL, Tavazzi L; GISSI-HF Investigators. Prognostic effects of rosuvastatin in patients with co-existing chronic obstructive pulmonary disease and chronic heart failure: A sub-analysis of GISSI-HF trial. Pulm Pharmacol Ther. 2017 Jun;44:16-23. doi: 10.1016/j.pupt.2017.03.001. Epub 2017 Mar 3.

    PubMed 28263812

  • Florea VG, Rector TS, Anand IS, Cohn JN. Heart Failure With Improved Ejection Fraction: Clinical Characteristics, Correlates of Recovery, and Survival: Results From the Valsartan Heart Failure Trial. Circ Heart Fail. 2016 Jul;9(7):e003123. doi: 10.1161/CIRCHEARTFAILURE.116.003123.

    PubMed 27413037

  • Damman K, Masson S, Hillege HL, Voors AA, van Veldhuisen DJ, Rossignol P, Proietti G, Barbuzzi S, Nicolosi GL, Tavazzi L, Maggioni AP, Latini R. Tubular damage and worsening renal function in chronic heart failure. JACC Heart Fail. 2013 Oct;1(5):417-24. doi: 10.1016/j.jchf.2013.05.007. Epub 2013 Sep 11.

    PubMed 24621973

  • Barlera S, Tavazzi L, Franzosi MG, Marchioli R, Raimondi E, Masson S, Urso R, Lucci D, Nicolosi GL, Maggioni AP, Tognoni G; GISSI-HF Investigators. Predictors of mortality in 6975 patients with chronic heart failure in the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure trial: proposal for a nomogram. Circ Heart Fail. 2013 Jan;6(1):31-9. doi: 10.1161/CIRCHEARTFAILURE.112.967828. Epub 2012 Nov 14.

    PubMed 23152490

  • La Rovere MT, Pinna GD, Maestri R, Barlera S, Bernardinangeli M, Veniani M, Nicolosi GL, Marchioli R, Tavazzi L; GISSI-HF Investigators. Autonomic markers and cardiovascular and arrhythmic events in heart failure patients: still a place in prognostication? Data from the GISSI-HF trial. Eur J Heart Fail. 2012 Dec;14(12):1410-9. doi: 10.1093/eurjhf/hfs126. Epub 2012 Jul 30.

    PubMed 22851700

  • Latini R, Gullestad L, Masson S, Nymo SH, Ueland T, Cuccovillo I, Vardal M, Bottazzi B, Mantovani A, Lucci D, Masuda N, Sudo Y, Wikstrand J, Tognoni G, Aukrust P, Tavazzi L; Investigators of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) and GISSI-Heart Failure (GISSI-HF) trials. Pentraxin-3 in chronic heart failure: the CORONA and GISSI-HF trials. Eur J Heart Fail. 2012 Sep;14(9):992-9. doi: 10.1093/eurjhf/hfs092. Epub 2012 Jun 27.

    PubMed 22740508

  • Masson S, Anand I, Favero C, Barlera S, Vago T, Bertocchi F, Maggioni AP, Tavazzi L, Tognoni G, Cohn JN, Latini R; Valsartan Heart Failure Trial (Val-HeFT) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) Investigators. Serial measurement of cardiac troponin T using a highly sensitive assay in patients with chronic heart failure: data from 2 large randomized clinical trials. Circulation. 2012 Jan 17;125(2):280-8. doi: 10.1161/CIRCULATIONAHA.111.044149. Epub 2011 Dec 2.

    PubMed 22139751

  • Damman K, Masson S, Hillege HL, Maggioni AP, Voors AA, Opasich C, van Veldhuisen DJ, Montagna L, Cosmi F, Tognoni G, Tavazzi L, Latini R. Clinical outcome of renal tubular damage in chronic heart failure. Eur Heart J. 2011 Nov;32(21):2705-12. doi: 10.1093/eurheartj/ehr190. Epub 2011 Jun 11.

    PubMed 21666249

  • 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. 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. Am Heart J. 2011 Feb;161(2):338-343.e1. doi: 10.1016/j.ahj.2010.10.032.

    PubMed 21315217

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing n-3 PUFA and Rosuvastatin in people with Heart Failure, run by Gruppo di Ricerca GISSI at 337 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 337 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: from enrollment to 1252 deaths in R2 arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00336336, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.

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