GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
Launched by GRUPPO DI RICERCA GISSI · Jun 12, 2006
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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)
- Exclusion Criteria:
- 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;
- • 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.
- EXCLUSION CRITERIA FOR R2 (statin hypothesis):
- • current serum creatinine level \>2.5 mg/dL;
- • current ALT, AST level \>1.5 times the upper normal limit;
- • current CPK upper normal limits.
About Gruppo Di Ricerca Gissi
Gruppo di Ricerca GISSI is a prominent clinical research organization dedicated to advancing medical knowledge and improving patient outcomes through rigorous scientific investigation. With a focus on cardiovascular and metabolic diseases, GISSI conducts multi-center clinical trials that aim to evaluate the efficacy and safety of innovative therapeutic interventions. The organization is committed to fostering collaboration among healthcare professionals, researchers, and institutions to ensure the highest standards of research integrity and ethical practice. By translating research findings into clinical applications, GISSI plays a vital role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pozzuoli, , Italy
Bentivoglio, Bo, Italy
Sondalo, So, Italy
Agrigento, Ag, Italy
Canicatti', Ag, Italy
Licata, Ag, Italy
Acqui Terme, Al, Italy
Novi Ligure, Al, Italy
Ancona, An, Italy
Aosta, Ao, Italy
Ascoli Piceno, Ap, Italy
Fermo, Ap, Italy
San Benedetto Del Tronto, Ap, Italy
Avezzano, Aq, Italy
L'aquila, Aq, Italy
Arezzo, Ar, Italy
Cortona, Ar, Italy
Montevarchi, Ar, Italy
Asti, At, Italy
Bari Carbonara, Ba, Italy
Bari, Ba, Italy
Bari, Ba, Italy
Barletta, Ba, Italy
Cassano Delle Murge, Ba, Italy
Castellana Grotte, Ba, Italy
Putignano, Ba, Italy
Bergamo, Bg, Italy
Seriate, Bg, Italy
Seriate, Bg, Italy
Treviglio, Bg, Italy
Agordo, Bl, Italy
Belluno, Bl, Italy
Pieve Di Cadore, Bl, Italy
Bazzano, Bo, Italy
Bologna, Bo, Italy
Bologna, Bo, Italy
Loiano, Bo, Italy
Fasano, Br, Italy
Francavilla Fontana, Br, Italy
San Pietro Vernotico, Br, Italy
Brescia, Bs, Italy
Chiari, Bs, Italy
Desenzano Del Garda, Bs, Italy
Gavardo, Bs, Italy
Manerbio, Bs, Italy
Merano, Bz, Italy
Cagliari Monserrato, Ca, Italy
Cagliari, Ca, Italy
Cagliari, Ca, Italy
Cagliari, Ca, Italy
Cagliari, Ca, Italy
Cagliari, Ca, Italy
Larino, Cb, Italy
Termoli, Cb, Italy
Aversa, Ce, Italy
Caserta, Ce, Italy
Caserta, Ce, Italy
Marcianise, Ce, Italy
Piedimonte Matese, Ce, Italy
San Felice A Cancello, Ce, Italy
Lanciano, Ch, Italy
Vasto, Ch, Italy
Alba, Cn, Italy
Fossano, Cn, Italy
Saluzzo, Cn, Italy
Como, Co, Italy
Como, Co, Italy
Mariano Comense, Co, Italy
Menaggio, Co, Italy
Casalmaggiore, Cr, Italy
Cremona, Cr, Italy
Rivolta D'adda, Cr, Italy
Cariati, Cs, Italy
Castrovillari, Cs, Italy
Corigliano Calabro, Cs, Italy
Cosenza, Cs, Italy
Cosenza, Cs, Italy
Cosenza, Cs, Italy
Mormanno, Cs, Italy
Paola, Cs, Italy
Rogliano, Cs, Italy
Rossano, Cs, Italy
Trebisacce, Cs, Italy
Caltagirone, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catania, Ct, Italy
Catanzaro, Cz, Italy
Catanzaro, Cz, Italy
Località Germaneto Catanzaro, Cz, Italy
Nicosia, En, Italy
Piazza Armerina, En, Italy
Cesenatico, Fc, Italy
Cesena, Fc, Italy
Forli', Fc, Italy
Ferrara, Fe, Italy
Lagosanto, Fe, Italy
Cerignola, Fg, Italy
Foggia, Fg, Italy
Manfredonia, Fg, Italy
San Giovanni Rotondo, Fg, Italy
Bagno A Ripoli, Fi, Italy
Borgo San Lorenzo, Fi, Italy
Empoli, Fi, Italy
Firenze, Fi, Italy
Firenze, Fi, Italy
Firenze, Fi, Italy
Firenze, Fi, Italy
Fucecchio, Fi, Italy
Cassino, Fr, Italy
Sora, Fr, Italy
Genova Sampierdarena, Ge, Italy
Genova Sestri Ponente, Ge, Italy
Genova, Ge, Italy
Sestri Levante, Ge, Italy
Gorizia, Go, Italy
Grosseto, Gr, Italy
Massa Marittima, Gr, Italy
Orbetello, Gr, Italy
Sanremo, Im, Italy
Isernia, Is, Italy
Crotone, Kr, Italy
Mesoraca, Kr, Italy
Lecco, Lc, Italy
Casarano, Le, Italy
Galatina, Le, Italy
Gallipoli, Le, Italy
Lecce, Le, Italy
San Cesario Di Lecce, Le, Italy
Scorrano, Le, Italy
Tricase, Le, Italy
Cecina, Li, Italy
Livorno, Li, Italy
Piombino, Li, Italy
Formia, Lt, Italy
Gaeta, Lt, Italy
Latina, Lt, Italy
Minturno, Lt, Italy
Terracina, Lt, Italy
Castelnuovo Garfagnana, Lu, Italy
Lido Di Camaiore, Lu, Italy
Camerino, Mc, Italy
Macerata, Mc, Italy
Barcellona Pozzo Di Gotto, Me, Italy
Messina, Me, Italy
Milazzo, Me, Italy
Patti, Me, Italy
Sant'agata Di Militello, Me, Italy
Taormina, Me, Italy
Cernusco Sul Naviglio, Mi, Italy
Giussano, Mi, Italy
Legnano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Monza, Mi, Italy
Monza, Mi, Italy
Passirana Rho, Mi, Italy
Sesto San Giovanni, Mi, Italy
Vimercate, Mi, Italy
Vizzolo Predabissi, Mi, Italy
Castiglione Delle Stiviere, Mn, Italy
Mantova, Mn, Italy
Pieve Di Coriano, Mn, Italy
Modena, Mo, Italy
Pavullo Nel Frignano, Mo, Italy
Sassuolo, Mo, Italy
Carrara, Ms, Italy
Massa, Ms, Italy
Massa, Ms, Italy
Matera, Mt, Italy
Policoro, Mt, Italy
Nuoro, Nu, Italy
Cefalu', Pa, Italy
Palermo, Pa, Italy
Palermo, Pa, Italy
Palermo, Pa, Italy
Palermo, Pa, Italy
Palermo, Pa, Italy
Palermo, Pa, Italy
Termini Imerese, Pa, Italy
Camposampiero, Pd, Italy
Cittadella, Pd, Italy
Este, Pd, Italy
Penne, Pe, Italy
Pescara, Pe, Italy
Città Di Castello, Pg, Italy
Foligno, Pg, Italy
Gubbio, Pg, Italy
Passignano Sul Trasimeno, Pg, Italy
Todi, Pg, Italy
Pordenone, Pn, Italy
San Vito Al Tagliamento, Pn, Italy
Prato, Po, Italy
Fidenza, Pr, Italy
Parma, Pr, Italy
Urbino, Pu, Italy
Mede, Pv, Italy
Montescano, Pv, Italy
Pavia, Pv, Italy
Pavia, Pv, Italy
Vigevano, Pv, Italy
Vigevano, Pv, Italy
Voghera, Pv, Italy
Lagonegro, Pz, Italy
Potenza, Pz, Italy
Venosa, Pz, Italy
Cotignola, Ra, Italy
Reggio Calabria, Rc, Italy
Scilla, Rc, Italy
Castelnuovo Ne' Monti, Re, Italy
Correggio, Re, Italy
Ragusa, Rg, Italy
Ragusa, Rg, Italy
Rieti, Ri, Italy
Albano Laziale, Rm, Italy
Civitavecchia, Rm, Italy
Colleferro, Rm, Italy
Frascati, Rm, Italy
Marino, Rm, Italy
Monterotondo, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Roma, Rm, Italy
Subiaco, Rm, Italy
Tivoli, Rm, Italy
Velletri, Rm, Italy
Riccione, Rn, Italy
Rimini, Rn, Italy
Adria, Ro, Italy
Rovigo, Ro, Italy
Battipaglia, Sa, Italy
Mercato San Severino, Sa, Italy
Nocera Inferiore, Sa, Italy
Oliveto Citra, Sa, Italy
Salerno, Sa, Italy
Sapri, Sa, Italy
Scafati, Sa, Italy
Vallo Della Lucania, Sa, Italy
Montepulciano, Si, Italy
Poggibonsi, Si, Italy
Siena, Si, Italy
Morbegno, So, Italy
Sondalo, So, Italy
Sondrio, So, Italy
La Spezia, Sp, Italy
Sarzana Loc. Santa Caterina, Sp, Italy
Siracusa, Sr, Italy
Sassari, Ss, Italy
Thiesi, Ss, Italy
Castellaneta, Ta, Italy
Martina Franca, Ta, Italy
Mottola, Ta, Italy
Taranto, Ta, Italy
Taranto, Ta, Italy
Teramo, Te, Italy
Arco, Tn, Italy
Trento, Tn, Italy
Moncalieri, To, Italy
Orbassano, To, Italy
Pinerolo, To, Italy
Susa, To, Italy
Torino, To, Italy
Torino, To, Italy
Torino, To, Italy
Torino, To, Italy
Castelvetrano, Tp, Italy
Erice, Tp, Italy
Mazara Del Vallo, Tp, Italy
Terni, Tr, Italy
Trieste, Ts, Italy
Conegliano Veneto, Tv, Italy
Conegliano Veneto, Tv, Italy
Treviso, Tv, Italy
Palmanova, Ud, Italy
San Daniele Del Friuli, Ud, Italy
Tolmezzo, Ud, Italy
Udine, Ud, Italy
Gallarate, Va, Italy
Saronno, Va, Italy
Somma Lombardo, Va, Italy
Tradate, Va, Italy
Varese, Va, Italy
Varese, Va, Italy
Verbania, Vb, Italy
Dolo, Ve, Italy
Mestre, Ve, Italy
Mirano, Ve, Italy
Portogruaro, Ve, Italy
Venezia, Ve, Italy
Noventa Vicentina, Vi, Italy
Bovolone, Vr, Italy
Legnago, Vr, Italy
Negrar, Vr, Italy
San Bonifacio, Vr, Italy
Verona, Vr, Italy
Villafranca Di Verona, Vr, Italy
Soriano Calabro, Vv, Italy
Vibo Valentia, Vv, Italy
Borgomanero, , Italy
Boscotrecase, , Italy
Castellammare Di Stabia, , Italy
Frattaminore, , Italy
Giugliano In Campania, , Italy
Milano, , Italy
Napoli, , Italy
Napoli, , Italy
Napoli, , Italy
Napoli, , Italy
Napoli, , Italy
Nola, , Italy
Sorrento, , Italy
Veruno, , Italy
Lugano, , Switzerland
Patients applied
Trial Officials
Luigi Tavazzi, MD
Study Chair
Policlinico San Matteo di Pavia
Gianni Tognoni, MD
Study Chair
Consorzio Mario Negri Sud
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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