GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure
1 other identifier
interventional
6,975
2 countries
337
Brief 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. 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Aug 2002
Longer than P75 for phase_3 heart-failure
337 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 12, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedAugust 14, 2015
September 1, 2010
5.7 years
June 12, 2006
August 13, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
All-cause mortality
from enrollment to 1252 deaths in R2 arm
All cause mortality or hospitalizations for any reason
from enrollment to 1252 deaths
Secondary Outcomes (8)
Cardiovascular mortality
from enrollment to 1252 deaths in R2 arm
Cardiovascular mortality or hospitalization for heart failure or for any reasons
from enrollment to 1252 deaths in R2 arm
Sudden cardiac death
from enrollment to 1252 deaths in R2 arm
Hospitalizations for any reasons
from enrollment to 1252 deaths in R2 arm
Hospitalization for Cardiovascular reasons
from enrollment to 1252 deaths in R2 arm
- +3 more secondary outcomes
Study Arms (4)
1
EXPERIMENTALN-3PUFA
2
PLACEBO COMPARATOR3
EXPERIMENTALRosuvastatin
4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (337)
Ospedale San Giovanni di Dio
Agrigento, AG, 92100, Italy
Ospedale Barone Lombardo
Canicattì, AG, 92024, Italy
Ospedale San Giacomo D'Altopasso
Licata, AG, 92027, Italy
Ospedale Civile
Acqui Terme, AL, 15011, Italy
Ospedale San Giacomo
Novi Ligure, AL, 15067, Italy
Presidio Cardiologico G.M. Lancisi
Ancona, AN, 60122, Italy
Ospedale Generale Regionale
Aosta, AO, 11100, Italy
Osp. Gen.le Prov.le C.G.Mazzoni
Ascoli Piceno, AP, 63100, Italy
Ospedale Civile Augusto Murri
Fermo, AP, 63023, Italy
Ospedale Madonna del Soccorso
San Benedetto del Tronto, AP, 63039, Italy
Ospedale Civile SS.Filippo e Nicola
Avezzano, AQ, 67051, Italy
Presidio Ospedaliero San Salvatore
L’Aquila, AQ, 67100, Italy
Ospedale San Donato
Arezzo, AR, 52100, Italy
Ospedale Valdichiana Santa Margherita
Cortona, AR, 52040, Italy
Osp.Valdarno "S.Maria della Gruccia"
Montevarchi, AR, 52027, Italy
Ospedale Cardinal Massaia
Asti, AT, 14100, Italy
Ospedale San Paolo
Bari, BA, 70123, Italy
Ospedale Consorziale Policlinico
Bari, BA, 70124, Italy
Ospedale di Venere
Bari - Carbonara, BA, 70012, Italy
Ospedale Monsignor Angelo R. di Miccoli
Barletta, BA, 70051, Italy
Fondazione S. Maugeri Clinica del Lavoro
Cassano delle Murge, BA, 70020, Italy
IRCCS Saverio De Bellis
Castellana Grotte, BA, 70013, Italy
Ospedale Santa Maria degli Angeli
Putignano, BA, 70017, Italy
Ospedali Riuniti di Bergamo
Bergamo, BG, 24128, Italy
Ospedale Bolognini
Seriate, BG, 24068, Italy
Presidio Gazzaniga c/o Osp. Seriate
Seriate, BG, 24068, Italy
Ospedali Riuniti di Treviglio
Treviglio, BG, 24047, Italy
Ospedale Civile
Agordo, BL, 32021, Italy
Ospedale Civile
Belluno, BL, 32100, Italy
Ospedale Civile del Cadore
Pieve di Cadore, BL, 32044, Italy
Ospedale Dossetti
Bazzano, BO, 40053, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, 40010, Italy
Ospedale Policlinico S.Orsola-M.Malpighi
Bologna, BO, 40138, Italy
Ospedale Bellaria
Bologna, BO, 40139, Italy
Ospedale Civile Simiani
Loiano, BO, 40050, Italy
Ospedale Umberto I
Fasano, BR, 72015, Italy
Ospedale Civile Dario Camberlingo
Francavilla Fontana, BR, 72021, Italy
Ospedale N. Melli
San Pietro Vernotico, BR, 72027, Italy
Spedali Civili
Brescia, BS, 25123, Italy
Ospedale Civile Mellini
Chiari, BS, 25032, Italy
Azienda Ospedaliera
Desenzano del Garda, BS, 25015, Italy
Presidio Ospedaliero
Gavardo, BS, 25085, Italy
Ospedale di Manerbio
Manerbio, BS, 25025, Italy
Ospedale Generale Provinciale
Merano, BZ, 39012, Italy
Osedale A. Businco
Cagliari, CA, 09121, Italy
Presidio Ospedaliero SS. Trinita'
Cagliari, CA, 09121, Italy
Ospedale Marino
Cagliari, CA, 09126, Italy
Azienda Osped. G.Brotzu-S.Michele (S.S.D.coord.Scompenso)
Cagliari, CA, 09134, Italy
Azienda Ospedaliera G. Brotzu - S. Michele
Cagliari, CA, 09134, Italy
Universita'
Cagliari-Monserrato, CA, 09042, Italy
Ospedale Civile G. Vietri
Larino, CB, 86035, Italy
Ospedale San Timoteo
Termoli, CB, 86039, Italy
Presidio Ospedaliero Moscati
Aversa, CE, 81031, Italy
Az. Ospedaliera S.Anna e S.Sebastiano
Caserta, CE, 81100, Italy
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, CE, 81100, Italy
P.O. Marcianese ASL Caserta 1
Marcianise, CE, 81025, Italy
Ospedale Civile Ave Gratia Plena
Piedimonte Matese, CE, 81016, Italy
Ospedale Ave Gratia Plena
San Felice A Cancello, CE, 81027, Italy
Ospedale Renzetti
Lanciano, CH, 66034, Italy
Ospedale San Pio da Pietrelcina
Vasto, CH, 66054, Italy
Ospedale Civile San Lazzaro
Alba, CN, 12051, Italy
Ospedale Maggiore SS. Trinita'
Fossano, CN, 12045, Italy
Ospedale Civile Saluzzo
Saluzzo, CN, 12037, Italy
Ospedale Generale di Zona Valduce
Como, CO, 22100, Italy
Ospedale S. Anna
Como, CO, 22100, Italy
A.O. S. Anna-Presidio di Mariano Comense
Mariano Comense, Co, 22066, Italy
Ospedale di Menaggio
Menaggio, CO, 22017, Italy
Ospedale Civile Oglio Po
Casalmaggiore, CR, 26041, Italy
Istituti Ospitalieri di Cremona
Cremona, CR, 26100, Italy
Ospedale Santa Marta
Rivolta d'Adda, CR, 26027, Italy
Ospedale V. Cosentino
Cariati, CS, 87063, Italy
Ospedale Civile Ferrari
Castrovillari, CS, 87012, Italy
Ospedale Civile Guido Compagna
Corigliano Calabro, CS, 87064, Italy
INRCA Istituto Cardiovasculop.Senili
Cosenza, CS, 87100, Italy
Ospedale Santissima Annunziata
Cosenza, CS, 87100, Italy
Presidio Ospedaliero Mariano Santo
Cosenza, CS, 87100, Italy
Ospedale Civile Minervini
Mormanno, CS, 87026, Italy
Ospedale San Francesco di Paola
Paola, CS, 87027, Italy
Ospedale Santa Barbara
Rogliano, CS, 87054, Italy
Ospedale Civile N. Giannettasio
Rossano, CS, 87068, Italy
Ospedale Civile G. Chidichimo
Trebisacce, CS, 87075, Italy
Ospedale Generale Provinciale Gravina
Caltagirone, CT, 95041, Italy
Ospedale Garibaldi - Nesima
Catania, CT, 95122, Italy
Ospedale Garibaldi-Nesima
Catania, CT, 95122, Italy
Ospedale Ferrarotto
Catania, CT, 95124, Italy
Ospedale Garibaldi - Centro
Catania, CT, 95124, Italy
Ospedale Vittorio Emanuele II
Catania, CT, 95124, Italy
Ospedale Cannizzaro (U.O.Cardiologia)
Catania, CT, 95126, Italy
Ospedle Cannizzaro (UTIC)
Catania, CT, 95126, Italy
Azienda Ospedaliera Mater Domini
Catanzaro, CZ, 88100, Italy
Ospedale Civile Pugliese
Catanzaro, CZ, 88100, Italy
Azienda Ospedaliera Mater Domini
Località Germaneto - Catanzaro, CZ, 88100, Italy
Ospedale G. Basilotta
Nicosia, EN, 94014, Italy
Ospedale M. Chiello
Piazza Armerina, EN, 94015, Italy
Ospedale M. Bufalini-G. Marconi
Cesena, FC, 47023, Italy
Ospedale M.Bufalini-G.Marconi
Cesenatico, FC, 47042, Italy
Ospedale G.B.Morgagni-L.Pierantoni
Forlì, FC, 47100, Italy
Arcispedale Sant'Anna
Ferrara, FE, 44100, Italy
Ospedale del Delta
Lagosanto, FE, 44023, Italy
Ospedale Civile Giuseppe Tatarella
Cerignola, FG, 71042, Italy
Ospedali Riuniti
Foggia, FG, 71100, Italy
Ospedale San Camillo De Lellis
Manfredonia, FG, 71043, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, 71013, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, FI, 50011, Italy
Presidio Ospedaliero del Mugello
Borgo San Lorenzo, FI, 50032, Italy
Ospedale Civile San Giuseppe
Empoli, FI, 50053, Italy
Ospedale Santa Maria Nuova
Florence, FI, 50122, Italy
Presidio Ospedaliero di Camerata
Florence, FI, 50133, Italy
Az. Ospedaliero-Universitaria Careggi
Florence, FI, 50134, Italy
Az. Ospedaliero-Universitaria Careggi
Florence, FI, 50139, Italy
Az. Ospedaliero-Universitaria Careggi
Florence, FI, 50141, Italy
Nuovo Ospedale San Giovanni di Dio
Florence, FI, 50143, Italy
Ospedale San Pietro Igneo
Fucecchio, FI, 50054, Italy
Ospedale Santa Scolastica
Cassino, FR, 03043, Italy
Ospedale Civile SS. Trinita'
Sora, FR, 03039, Italy
Dimi-Disem
Genova, GE, 16132, Italy
Ospedali Civili di Sampierdarena
Genova-Sampierdarena, GE, 16149, Italy
Ospedale Padre Antero Micone
Genova-Sestri Ponente, GE, 16153, Italy
Ospedale Sestri Levante
Sestri Levante, GE, 16039, Italy
Presidio Ospedaliero di Gorizia
Gorizia, GO, 34170, Italy
Ospedale della Misericordia
Grosseto, GR, 58100, Italy
Ospedale S.Andrea-Alta Maremma
Massa Marittima, GR, 58024, Italy
Ospedale San Giovanni di Dio
Orbetello, GR, 58015, Italy
Presidio Ospedaliero
Sanremo, IM, 18038, Italy
Ospedale F. Veneziale
Isernia, IS, 86170, Italy
Ospedale Civile San Giovanni di Dio
Crotone, KR, 88900, Italy
Ospedale di Mesoraca
Mesoraca, KR, 88838, Italy
Ospedale Umberto I
Lecco, LC, 23900, Italy
Presidio Ospedaliero F. Ferrari
Casarano, LE, 73042, Italy
Ospedale Santa Caterina Novella
Galatina, LE, 73013, Italy
Ospedale Civile Sacro Cuore di Gesu'
Gallipoli, LE, 73014, Italy
Ospedale Vito Fazzi
Lecce, LE, 73100, Italy
Presidio Osped. Pneumologico Galateo
San Cesario di Lecce, LE, 73016, Italy
Ospedale Ignazio Veris Delli Ponti
Scorrano, LE, 73020, Italy
Ospedale Cardinale Panico
Tricase, LE, 73039, Italy
Ospedale Civile Bassa Val di Cecina
Cecina, LI, 57023, Italy
Ospedali Riuniti
Livorno, LI, 57124, Italy
Ospedale Villamarina
Piombino, LI, 57025, Italy
Ospedale del dono Svizzero
Formia, LT, 04023, Italy
Ospedale Civile
Gaeta, LT, 04024, Italy
Ospedale S. Maria Goretti
Latina, LT, 04100, Italy
Ospedale Generale di Zona
Minturno, LT, 04026, Italy
Ospedale Civile
Terracina, LT, 04019, Italy
Ospedale Santa Croce
Castelnuovo Garfagnana, LU, 55032, Italy
Nuovo Ospedale Versilia
Lido di Camaiore, LU, 55043, Italy
Ospedale Santa Maria della Pieta'
Camerino, MC, 62032, Italy
Ospedale Generale Provinciale
Macerata, MC, 62100, Italy
Nuovo Pres.Osp. Cutroni Zodda
Barcellona Pozzo di Gotto, ME, 98050, Italy
Ospedale Papardo
Messina, ME, 98158, Italy
Ospedale Civile
Milazzo, ME, 98057, Italy
Ospedale Barone Romeo
Patti, ME, 98066, Italy
P.O. Sant'Agata di Militello
Sant'Agata di Militello, ME, 98076, Italy
Presidio Ospedaliero San Vincenzo
Taormina, ME, 98039, Italy
Ospedale di Cernusco sul Naviglio
Cernusco sul Naviglio, MI, 20063, Italy
Ospedale Carlo Borella
Giussano, MI, 20034, Italy
Ospedale Civile
Legnano, MI, 20025, Italy
Ospedale Fatebenefratelli
Milan, MI, 20121, Italy
Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
Centro Cardiologico Monzino
Milan, MI, 20138, Italy
Ospedale San Paolo
Milan, MI, 20142, Italy
Ospedale San Carlo Borromeo
Milan, MI, 20153, Italy
Ospedale Niguarda-Villa Marelli
Milan, MI, 20159, Italy
Ospedale Niguarda
Milan, MI, 20162, Italy
Ospedale San Gerardo
Monza, MI, 20052, Italy
Policlinico di Monza
Monza, MI, 20052, Italy
Presidio Ospedaliero di Passirana
Passirana-Rho, MI, 20017, Italy
Ospedale di Sesto San Giovanni
Sesto San Giovanni, MI, 20099, Italy
Presidio Ospedaliero
Vimercate, MI, 20059, Italy
Ospedale di Vizzolo Predabissi
Vizzolo Predabissi, MI, 20077, Italy
Ospedale San Pellegrino
Castiglione delle Stiviere, MN, 46043, Italy
Presidio Ospedaliero C. Poma
Mantova, MN, 46100, Italy
Ospedali Destra Secchia
Pieve di Coriano, MN, 46020, Italy
Ospedale Policlinico
Modena, MO, 41100, Italy
Presidio Ospedaliero
Pavullo nel Frignano, MO, 41026, Italy
Nuovo Ospedale Civile di Sassuolo
Sassuolo, MO, 41049, Italy
Civico Ospedale Carrara
Carrara, MS, 54033, Italy
IFC CNR-Ospedale Pasquinucci
Massa, MS, 54100, Italy
Ospedale SS.Giacomo e Cristoforo
Massa, MS, 54100, Italy
Ospedale Madonna delle Grazie
Matera, MT, 75100, Italy
Ospedale Civile
Policoro, MT, 75025, Italy
Ospedale San Francesco
Nuoro, NU, 08100, Italy
Fondazione San Raffaele G. Giglio
Cefalù, PA, 90015, Italy
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, PA, 90123, Italy
A.R.N.A.S. Ospedale Civico e Benfratelli
Palermo, PA, 90127, Italy
Ospedale G.F. Ingrassia
Palermo, PA, 90129, Italy
Ospedale G.F. Ingrassia
Palermo, PA, 90132, Italy
Az. Osp. Villa Sofia CTO (Cardiologia II)
Palermo, PA, 90146, Italy
Ospedale V. Cervello
Palermo, PA, 90146, Italy
Presidio Ospedaliero Villa Sofia
Palermo, PA, 90146, Italy
Ospedale Pubblico S. Cimino
Termini Imerese, PA, 90018, Italy
Ospedale di Camposampiero
Camposampiero, PD, 35012, Italy
Ospedale di Cittadella
Cittadella, PD, 35013, Italy
Ospedale Generale Provinciale
Este, PD, 35042, Italy
Ospedale Civile San Massimo
Penne, PE, 65017, Italy
Ospedale Civile dello Spirito Santo
Pescara, PE, 65124, Italy
Ospedale Alta Valle del Tevere
Città di Castello, PG, 06012, Italy
Nuovo Ospedale San Giovanni Battista
Foligno, PG, 06034, Italy
Ospedale Gubbio-Gualdo Tadino
Gubbio, PG, 06024, Italy
Centro Osp.Riabilit.Intensiva (CORI)
Passignano sul Trasimeno, PG, 06065, Italy
Presidio Ospedaliero
Todi, PG, 06059, Italy
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, PN, 33170, Italy
Ospedale Civile
San Vito al Tagliamento, PN, 33078, Italy
Ospedale Misericordia e Dolce
Prato, PO, 59100, Italy
Ospedale Civile
Fidenza, PR, 43036, Italy
Az. Ospedaliera Universitaria di Parma
Parma, PR, 43100, Italy
Ospedale Santa Maria della Misericordia
Urbino, PU, 61029, Italy
Ospedale San Martino
Mede, PV, 27035, Italy
Fondazione S.Maugeri Clinica del Lavoro
Montescano, PV, 27040, Italy
IRCCS - Fondazione Salvatore Maugeri
Pavia, PV, 27100, Italy
Ospedale Policlinico San Matteo IRCCS
Pavia, PV, 27100, Italy
Istituto Clinico Beato Matteo
Vigevano, PV, 27029, Italy
Ospedale Civile
Vigevano, PV, 27029, Italy
Ospedale Civile
Voghera, PV, 27058, Italy
Ospedale Generale di Zona
Lagonegro, PZ, 85042, Italy
Azienda Ospedaliera San Carlo
Potenza, PZ, 85100, Italy
Ospedale San Francesco
Venosa, PZ, 85029, Italy
Villa Maria Cecilia Hospital
Cotignola, RA, 48010, Italy
Policlinico Madonna della Consolazione
Reggio Calabria, RC, 89124, Italy
Ospedale Scillesi D'America
Scilla, RC, 89024, Italy
Ospedale Scillesi D'America
Scilla, RC, 89058, Italy
Ospedale Sant'Anna
Castelnovo ne' Monti, Re, 42035, Italy
Ospedale Civile San Sebastiano
Correggio, RE, 42015, Italy
Ospedale Civile
Ragusa, RG, 97100, Italy
Ospedale M.P. Arezzo
Ragusa, RG, 97100, Italy
P.O. San Camillo De Lellis
Rieti, RI, 02100, Italy
Ospedali Riuniti Albano-Genzano
Albano Laziale, RM, 00041, Italy
Ospedale Civile San Paolo
Civitavecchia, RM, 00053, Italy
Ospedale Generale Zona Parodi Delfino
Colleferro, RM, 00034, Italy
Ospedale San Sebastiano Martire
Frascati, RM, 00044, Italy
Ospedale San Giuseppe
Marino, RM, 00047, Italy
Ospedale di Monterotondo
Monterotondo, RM, 00015, Italy
Campus Biomedico
Roma, RM, 00128, Italy
Ospedale San Filippo Neri
Roma, RM, 00135, Italy
Ospedale Sant'Eugenio
Roma, RM, 00144, Italy
Ospedale C. Forlanini
Roma, RM, 00149, Italy
Ospedale San Camillo
Roma, RM, 00149, Italy
Ospedale San Camillo
Roma, RM, 00152, Italy
Ospedale Sandro Pertini
Roma, RM, 00157, Italy
Policlinico Umberto Primo
Roma, RM, 00161, Italy
Ospedale San Carlo di Nancy
Roma, RM, 00165, Italy
Presidio Ospedaliero Villa Betania
Roma, RM, 00165, Italy
Ospedale Generale di Zona "Cristo Re"
Roma, RM, 00167, Italy
Ospedale Fatebenefratelli
Roma, RM, 00168, Italy
Policlinico Agostino Gemelli
Roma, RM, 00168, Italy
I.N.R.C.A.
Roma, RM, 00189, Italy
Ospedale Santo Spirito
Roma, RM, 00193, Italy
Ospedale A. Angelucci
Subiaco, RM, 00028, Italy
Ospedale San Giovanni Evangelista
Tivoli, RM, 00019, Italy
Ospedale Civile
Velletri, RM, 00049, Italy
Ospedale G. Ceccarini
Riccione, RN, 47838, Italy
Ospedale Infermi
Rimini, RN, 47900, Italy
Ospedale Civile
Adria, RO, 45011, Italy
Presidio Ospedaliero
Rovigo, RO, 45100, Italy
Presidio Ospedaliero S.Maria della Speranza
Battipaglia, SA, 84091, Italy
Ospedale G. Fucito
Mercato San Severino, SA, 84085, Italy
Ospedale Civile
Nocera Inferiore, SA, 84014, Italy
Ospedale San Francesco D'Assisi
Oliveto Citra, SA, 84020, Italy
A.O. S.Giovanni di Dio e Ruggi di Aragona
Salerno, SA, 84131, Italy
Ospedale dell'Immacolata
Sapri, SA, 84073, Italy
Ospedale Civile
Scafati, SA, 84018, Italy
Ospedale San Luca
Vallo della Lucania, SA, 84078, Italy
Presidio Ospedaliero Valdichiana Senese
Montepulciano, SI, 53045, Italy
Presidio Ospedaliero
Poggibonsi, SI, 53034, Italy
Policlinico Santa Maria alle Scotte
Siena, SI, 53100, Italy
Ospedale Civile
Morbegno, SO, 23017, Italy
Ospedale E. Morelli
Sondalo, SO, 23035, Italy
Ospedale Civile
Sondrio, SO, 23100, Italy
Ospedale S. Andrea
La Spezia, SP, 19124, Italy
Ospedale San Bartolomeo
Sarzana - Loc. Santa Caterina, SP, 19038, Italy
Azienda Ospedaliera Umberto I
Syracuse, SR, 96100, Italy
Az. Ospedaliero Universitaria di Sassari
Sassari, SS, 07100, Italy
Ospedale Civile
Thiesi, SS, 07047, Italy
Ospedale Civile
Castellaneta, TA, 74011, Italy
Presidio Ospedaliero della Valle D'Itria
Martina Franca, TA, 74015, Italy
Ospedale Umberto I
Mottola, TA, 74017, Italy
Ospedale S. Giuseppe Moscati
Taranto, TA, 74100, Italy
Ospedale SS. Annunziata
Taranto, TA, 74100, Italy
Ospedale Civile G. Mazzini
Teramo, TE, 64100, Italy
Ospedale Alto Garda e Ledro
Arco, TN, 38062, Italy
Casa di Cura Villa Bianca
Trento, TN, 38100, Italy
Ospedale Santa Croce
Moncalieri, To, 10024, Italy
Ospedale San Luigi Gonzaga
Orbassano, TO, 10043, Italy
Ospedale Civile E. Agnelli
Pinerolo, TO, 10064, Italy
Presidio Ospedaliero
Susa, TO, 10059, Italy
Ospedale Evangelico Valdese
Torino, TO, 10125, Italy
Ospedale Martini
Torino, TO, 10142, Italy
Ospedale Maria Vittoria
Torino, TO, 10149, Italy
Presidio Ospedaliero Gradenigo
Torino, TO, 10153, Italy
Ospedale Civile Vittorio Emanuele II
Castelvetrano, TP, 91022, Italy
Ospedale Civile Sant'Antonio Abate
Erice, TP, 91016, Italy
Ospedale A. Ajello
Mazara del Vallo, TP, 91026, Italy
Azienda USL 4 Terni
Terni, TR, 05100, Italy
Azienda Ospedaliera - Univ. Ospedali Riuniti
Trieste, TS, 34149, Italy
Ospedale De Gironcoli
Conegliano Veneto, TV, 31015, Italy
Ospedale Santa Maria dei Battuti
Conegliano Veneto, TV, 31015, Italy
Ospedale Ca' Foncello
Treviso, TV, 31100, Italy
Ospedale di Ialmicco - Palmanova - Udine
Palmanova, UD, 33057, Italy
Ospedale S. Antonio
San Daniele del Friuli, UD, 33038, Italy
Ospedale Civile Sant'Antonio Abate
Tolmezzo, UD, 33028, Italy
Santa Maria della Misericordia
Udine, UD, 33100, Italy
Ospedale S. Antonio Abate
Gallarate, VA, 21013, Italy
Presidio Ospedaliero
Saronno, VA, 21047, Italy
Ospedale di Circolo A. Bellini
Somma Lombardo, VA, 21019, Italy
Fondazione S. Maugeri Clinica del Lavoro
Tradate, VA, 21049, Italy
Azienda Ospedaliera e Universitaria
Varese, VA, 21100, Italy
Ospedale del Ponte
Varese, VA, 21100, Italy
Ospedale Castelli
Verbania, VB, 28922, Italy
Ospedale Civile
Dolo, VE, 30031, Italy
Ospedale Civile Umberto I
Mestre, VE, 30171, Italy
Ospedale Civile
Mirano, VE, 30035, Italy
Ospedale Civile
Portogruaro, VE, 30026, Italy
Ospedali Civili Riuniti
Venezia, VE, 30122, Italy
Ospedale Civile
Noventa Vicentina, VI, 36025, Italy
Ospedale Civile San Biagio
Bovolone, VR, 37051, Italy
Ospedale Mater Salutis
Legnago, VR, 37045, Italy
Ospedale Sacro Cuore
Negrar, VR, 37024, Italy
Ospedale G. Fra Castoro
San Bonifacio, VR, 37047, Italy
Azienda Ospedaliera
Verona, VR, 37124, Italy
Ospedale di Villafranca
Villafranca di Verona, VR, 37069, Italy
Presidio Ospedaliero
Soriano Calabro, VV, 89831, Italy
Ospedale Civile G. Jazzolino
Vibo Valentia, VV, 89900, Italy
Ospedale SS. Trinita'
Borgomanero, 28021, Italy
Ospedale Civile di Boscotrecase
Boscotrecase, 80042, Italy
Opsedale San Leonardo
Castellammare di Stabia, 80053, Italy
Ospedale Civile San Giovanni di Dio
Frattaminore, 80027, Italy
Ospedale Generale di Zona
Giugliano in Campania, 80014, Italy
MIOspedale San Raffaele
Milan, 20132, Italy
AORN Cardarelli
Napoli, 80131, Italy
Azienda Ospedaliera Vincenzo Monaldi
Napoli, 80131, Italy
Fondazione Pascale
Napoli, 80131, Italy
Ospedale Domenico Cotugno
Napoli, 80131, Italy
Policlinico Universitario Federico II
Napoli, 80131, Italy
Pres.Ospedaliero S. Maria della Pieta'
Nola, 80035, Italy
Ospedale Santa Maria delle Grazie
Pozzuoli, 80078, Italy
Ospedale Santa Maria della Misericordia
Sorrento, 80067, Italy
Fondazione Salvatore Maugeri
Veruno, 28010, Italy
Cardiocentro Ticino
Lugano, 69000, Switzerland
Related Publications (16)
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.
PMID: 15302013BACKGROUNDTavazzi 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.
PMID: 18757090RESULTTavazzi 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.
PMID: 18757089RESULTCanepa 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.
PMID: 30580128DERIVEDMantovani 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.
PMID: 29477817DERIVEDDauriz 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.
PMID: 28679559DERIVEDRossi 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.
PMID: 28263812DERIVEDFlorea 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.
PMID: 27413037DERIVEDDamman 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.
PMID: 24621973DERIVEDBarlera 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.
PMID: 23152490DERIVEDLa 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.
PMID: 22851700DERIVEDLatini 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.
PMID: 22740508DERIVEDMasson 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.
PMID: 22139751DERIVEDDamman 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.
PMID: 21666249DERIVEDFinzi 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.
PMID: 21315217DERIVEDMaggioni AP, Fabbri G, Lucci D, Marchioli R, Franzosi MG, Latini R, Nicolosi GL, Porcu M, Cosmi F, Stefanelli S, Tognoni G, Tavazzi L; GISSI-HF Investigators. Effects of rosuvastatin on atrial fibrillation occurrence: ancillary results of the GISSI-HF trial. Eur Heart J. 2009 Oct;30(19):2327-36. doi: 10.1093/eurheartj/ehp357. Epub 2009 Aug 30.
PMID: 19717850DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luigi Tavazzi, MD
Policlinico San Matteo di Pavia
- STUDY CHAIR
Gianni Tognoni, MD
Consorzio Mario Negri Sud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2006
First Posted
June 13, 2006
Study Start
August 1, 2002
Primary Completion
April 1, 2008
Study Completion
May 1, 2008
Last Updated
August 14, 2015
Record last verified: 2010-09