Clinical trial NCT00336336: GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Gruppo di Ricerca GISSI
Sponsor class: OTHER
First posted: 2006-06-13
Enrollment: 6975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: All cause mortality or hospitalizations for any reason
timeFrame: from enrollment to 1252 deaths
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Cardiovascular mortality or hospitalization for heart failure or for any reasons
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Sudden cardiac death
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Hospitalizations for any reasons
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Hospitalization for Cardiovascular reasons
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Hospitalization for congestive heart failure
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Miocardial infarction
timeFrame: from enrollment to 1252 deaths in R2 arm
measure: Stroke
timeFrame: from enrollment to 1252 deaths in R2 arm
Other outcomes:
Locations:
city: Agrigento
country: Italy
facility: Ospedale San Giovanni di Dio
state: AG
city: Canicatti'
country: Italy
facility: Ospedale Barone Lombardo
state: AG
city: Licata
country: Italy
facility: Ospedale San Giacomo D'Altopasso
state: AG
city: Acqui Terme
country: Italy
facility: Ospedale Civile
state: AL
city: Novi Ligure
country: Italy
facility: Ospedale San Giacomo
state: AL
city: Ancona
country: Italy
facility: Presidio Cardiologico G.M. Lancisi
state: AN
city: Aosta
country: Italy
facility: Ospedale Generale Regionale
state: AO
city: Ascoli Piceno
country: Italy
facility: Osp. Gen.le Prov.le C.G.Mazzoni
state: AP
city: Fermo
country: Italy
facility: Ospedale Civile Augusto Murri
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city: San Benedetto del Tronto
country: Italy
facility: Ospedale Madonna del Soccorso
state: AP
city: Avezzano
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facility: Ospedale Civile SS.Filippo e Nicola
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city: L'Aquila
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facility: Presidio Ospedaliero San Salvatore
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city: Arezzo
country: Italy
facility: Ospedale San Donato
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city: Cortona
country: Italy
facility: Ospedale Valdichiana Santa Margherita
state: AR
city: Montevarchi
country: Italy
facility: Osp.Valdarno "S.Maria della Gruccia"
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city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
state: AT
city: Bari - Carbonara
country: Italy
facility: Ospedale di Venere
state: BA
city: Bari
country: Italy
facility: Ospedale San Paolo
state: BA
city: Bari
country: Italy
facility: Ospedale Consorziale Policlinico
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city: Barletta
country: Italy
facility: Ospedale Monsignor Angelo R. di Miccoli
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city: Cassano delle Murge
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facility: Fondazione S. Maugeri Clinica del Lavoro
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city: Castellana Grotte
country: Italy
facility: IRCCS Saverio De Bellis
state: BA
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country: Italy
facility: Ospedale Santa Maria degli Angeli
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country: Italy
facility: Ospedali Riuniti di Bergamo
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city: Seriate
country: Italy
facility: Ospedale Bolognini
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city: Seriate
country: Italy
facility: Presidio Gazzaniga c/o Osp. Seriate
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facility: Ospedali Riuniti di Treviglio
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facility: Ospedale Civile
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city: Belluno
country: Italy
facility: Ospedale Civile
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city: Pieve di Cadore
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facility: Ospedale Civile del Cadore
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facility: Ospedale Dossetti
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facility: Ospedale di Bentivoglio
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city: Bologna
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facility: Ospedale Policlinico S.Orsola-M.Malpighi
state: BO
city: Bologna
country: Italy
facility: Ospedale Bellaria
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city: Loiano
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facility: Ospedale Civile Simiani
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facility: Ospedale Umberto I
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city: Francavilla Fontana
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facility: Ospedale Civile Dario Camberlingo
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city: San Pietro Vernotico
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facility: Ospedale N. Melli
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city: Brescia
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facility: Spedali Civili
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facility: Ospedale Civile Mellini
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city: Desenzano del Garda
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facility: Azienda Ospedaliera
state: BS
city: Gavardo
country: Italy
facility: Presidio Ospedaliero
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facility: Ospedale di Manerbio
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facility: Ospedale Generale Provinciale
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city: Cagliari-Monserrato
country: Italy
facility: Universita'
state: CA
city: Cagliari
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facility: Osedale A. Businco
state: CA
city: Cagliari
country: Italy
facility: Presidio Ospedaliero SS. Trinita'
state: CA
city: Cagliari
country: Italy
facility: Ospedale Marino
state: CA
city: Cagliari
country: Italy
facility: Azienda Osped. G.Brotzu-S.Michele (S.S.D.coord.Scompenso)
state: CA
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu - S. Michele
state: CA
city: Larino
country: Italy
facility: Ospedale Civile G. Vietri
state: CB
city: Termoli
country: Italy
facility: Ospedale San Timoteo
state: CB
city: Aversa
country: Italy
facility: Presidio Ospedaliero Moscati
state: CE
city: Caserta
country: Italy
facility: Az. Ospedaliera S.Anna e S.Sebastiano
state: CE
city: Caserta
country: Italy
facility: Azienda Ospedaliera Sant'Anna e San Sebastiano
state: CE
city: Marcianise
country: Italy
facility: P.O. Marcianese ASL Caserta 1
state: CE
city: Piedimonte Matese
country: Italy
facility: Ospedale Civile Ave Gratia Plena
state: CE
city: San Felice a Cancello
country: Italy
facility: Ospedale Ave Gratia Plena
state: CE
city: Lanciano
country: Italy
facility: Ospedale Renzetti
state: CH
city: Vasto
country: Italy
facility: Ospedale San Pio da Pietrelcina
state: CH
city: Alba
country: Italy
facility: Ospedale Civile San Lazzaro
state: CN
city: Fossano
country: Italy
facility: Ospedale Maggiore SS. Trinita'
state: CN
city: Saluzzo
country: Italy
facility: Ospedale Civile Saluzzo
state: CN
city: Como
country: Italy
facility: Ospedale Generale di Zona Valduce
state: CO
city: Como
country: Italy
facility: Ospedale S. Anna
state: CO
city: Mariano Comense
country: Italy
facility: A.O. S. Anna-Presidio di Mariano Comense
state: Co
city: Menaggio
country: Italy
facility: Ospedale di Menaggio
state: CO
city: Casalmaggiore
country: Italy
facility: Ospedale Civile Oglio Po
state: CR
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona
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city: Rivolta D'Adda
country: Italy
facility: Ospedale Santa Marta
state: CR
city: Cariati
country: Italy
facility: Ospedale V. Cosentino
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city: Castrovillari
country: Italy
facility: Ospedale Civile Ferrari
state: CS
city: Corigliano Calabro
country: Italy
facility: Ospedale Civile Guido Compagna
state: CS
city: Cosenza
country: Italy
facility: INRCA Istituto Cardiovasculop.Senili
state: CS
city: Cosenza
country: Italy
facility: Ospedale Santissima Annunziata
state: CS
city: Cosenza
country: Italy
facility: Presidio Ospedaliero Mariano Santo
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city: Mormanno
country: Italy
facility: Ospedale Civile Minervini
state: CS
city: Paola
country: Italy
facility: Ospedale San Francesco di Paola
state: CS
city: Rogliano
country: Italy
facility: Ospedale Santa Barbara
state: CS
city: Rossano
country: Italy
facility: Ospedale Civile N. Giannettasio
state: CS
city: Trebisacce
country: Italy
facility: Ospedale Civile G. Chidichimo
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city: Caltagirone
country: Italy
facility: Ospedale Generale Provinciale Gravina
state: CT
city: Catania
country: Italy
facility: Ospedale Garibaldi - Nesima
state: CT
city: Catania
country: Italy
facility: Ospedale Garibaldi-Nesima
state: CT
city: Catania
country: Italy
facility: Ospedale Ferrarotto
state: CT
city: Catania
country: Italy
facility: Ospedale Garibaldi - Centro
state: CT
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele II
state: CT
city: Catania
country: Italy
facility: Ospedale Cannizzaro (U.O.Cardiologia)
state: CT
city: Catania
country: Italy
facility: Ospedle Cannizzaro (UTIC)
state: CT
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
state: CZ
city: Catanzaro
country: Italy
facility: Ospedale Civile Pugliese
state: CZ
city: Località Germaneto - Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
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city: Nicosia
country: Italy
facility: Ospedale G. Basilotta
state: EN
city: Piazza Armerina
country: Italy
facility: Ospedale M. Chiello
state: EN
city: Cesenatico
country: Italy
facility: Ospedale M.Bufalini-G.Marconi
state: FC
city: Cesena
country: Italy
facility: Ospedale M. Bufalini-G. Marconi
state: FC
city: Forli'
country: Italy
facility: Ospedale G.B.Morgagni-L.Pierantoni
state: FC
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
state: FE
city: Lagosanto
country: Italy
facility: Ospedale del Delta
state: FE
city: Cerignola
country: Italy
facility: Ospedale Civile Giuseppe Tatarella
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city: Foggia
country: Italy
facility: Ospedali Riuniti
state: FG
city: Manfredonia
country: Italy
facility: Ospedale San Camillo De Lellis
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city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: FG
city: Bagno a Ripoli
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facility: Ospedale Santa Maria Annunziata
state: FI
city: Borgo San Lorenzo
country: Italy
facility: Presidio Ospedaliero del Mugello
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city: Empoli
country: Italy
facility: Ospedale Civile San Giuseppe
state: FI
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova
state: FI
city: Firenze
country: Italy
facility: Presidio Ospedaliero di Camerata
state: FI
city: Firenze
country: Italy
facility: Az. Ospedaliero-Universitaria Careggi
state: FI
city: Firenze
country: Italy
facility: Az. Ospedaliero-Universitaria Careggi
state: FI
city: Firenze
country: Italy
facility: Az. Ospedaliero-Universitaria Careggi
state: FI
city: Firenze
country: Italy
facility: Nuovo Ospedale San Giovanni di Dio
state: FI
city: Fucecchio
country: Italy
facility: Ospedale San Pietro Igneo
state: FI
city: Cassino
country: Italy
facility: Ospedale Santa Scolastica
state: FR
city: Sora
country: Italy
facility: Ospedale Civile SS. Trinita'
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city: Genova-Sampierdarena
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facility: Ospedali Civili di Sampierdarena
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city: Genova-Sestri Ponente
country: Italy
facility: Ospedale Padre Antero Micone
state: GE
city: Genova
country: Italy
facility: Dimi-Disem
state: GE
city: Sestri Levante
country: Italy
facility: Ospedale Sestri Levante
state: GE
city: Gorizia
country: Italy
facility: Presidio Ospedaliero di Gorizia
state: GO
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
state: GR
city: Massa Marittima
country: Italy
facility: Ospedale S.Andrea-Alta Maremma
state: GR
city: Orbetello
country: Italy
facility: Ospedale San Giovanni di Dio
state: GR
city: Sanremo
country: Italy
facility: Presidio Ospedaliero
state: IM
city: Isernia
country: Italy
facility: Ospedale F. Veneziale
state: IS
city: Crotone
country: Italy
facility: Ospedale Civile San Giovanni di Dio
state: KR
city: Mesoraca
country: Italy
facility: Ospedale di Mesoraca
state: KR
city: Lecco
country: Italy
facility: Ospedale Umberto I
state: LC
city: Casarano
country: Italy
facility: Presidio Ospedaliero F. Ferrari
state: LE
city: Galatina
country: Italy
facility: Ospedale Santa Caterina Novella
state: LE
city: Gallipoli
country: Italy
facility: Ospedale Civile Sacro Cuore di Gesu'
state: LE
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: LE
city: San Cesario di Lecce
country: Italy
facility: Presidio Osped. Pneumologico Galateo
state: LE
city: Scorrano
country: Italy
facility: Ospedale Ignazio Veris Delli Ponti
state: LE
city: Tricase
country: Italy
facility: Ospedale Cardinale Panico
state: LE
city: Cecina
country: Italy
facility: Ospedale Civile Bassa Val di Cecina
state: LI
city: Livorno
country: Italy
facility: Ospedali Riuniti
state: LI
city: Piombino
country: Italy
facility: Ospedale Villamarina
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city: Formia
country: Italy
facility: Ospedale del dono Svizzero
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city: Gaeta
country: Italy
facility: Ospedale Civile
state: LT
city: Latina
country: Italy
facility: Ospedale S. Maria Goretti
state: LT
city: Minturno
country: Italy
facility: Ospedale Generale di Zona
state: LT
city: Terracina
country: Italy
facility: Ospedale Civile
state: LT
city: Castelnuovo Garfagnana
country: Italy
facility: Ospedale Santa Croce
state: LU
city: Lido di Camaiore
country: Italy
facility: Nuovo Ospedale Versilia
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city: Camerino
country: Italy
facility: Ospedale Santa Maria della Pieta'
state: MC
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale
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city: Barcellona Pozzo di Gotto
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facility: Nuovo Pres.Osp. Cutroni Zodda
state: ME
city: Messina
country: Italy
facility: Ospedale Papardo
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city: Milazzo
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facility: Ospedale Civile
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city: Patti
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facility: Ospedale Barone Romeo
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facility: P.O. Sant'Agata di Militello
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facility: Presidio Ospedaliero San Vincenzo
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city: Cernusco sul Naviglio
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facility: Ospedale di Cernusco sul Naviglio
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city: Giussano
country: Italy
facility: Ospedale Carlo Borella
state: MI
city: Legnano
country: Italy
facility: Ospedale Civile
state: MI
city: Milano
country: Italy
facility: Ospedale Fatebenefratelli
state: MI
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico
state: MI
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: MI
city: Milano
country: Italy
facility: Ospedale San Paolo
state: MI
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo
state: MI
city: Milano
country: Italy
facility: Ospedale Niguarda-Villa Marelli
state: MI
city: Milano
country: Italy
facility: Ospedale Niguarda
state: MI
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country: Italy
facility: Ospedale San Gerardo
state: MI
city: Monza
country: Italy
facility: Policlinico di Monza
state: MI
city: Passirana-Rho
country: Italy
facility: Presidio Ospedaliero di Passirana
state: MI
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country: Italy
facility: Ospedale di Sesto San Giovanni
state: MI
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country: Italy
facility: Presidio Ospedaliero
state: MI
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country: Italy
facility: Ospedale di Vizzolo Predabissi
state: MI
city: Castiglione delle Stiviere
country: Italy
facility: Ospedale San Pellegrino
state: MN
city: Mantova
country: Italy
facility: Presidio Ospedaliero C. Poma
state: MN
city: Pieve di Coriano
country: Italy
facility: Ospedali Destra Secchia
state: MN
city: Modena
country: Italy
facility: Ospedale Policlinico
state: MO
city: Pavullo nel Frignano
country: Italy
facility: Presidio Ospedaliero
state: MO
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo
state: MO
city: Carrara
country: Italy
facility: Civico Ospedale Carrara
state: MS
city: Massa
country: Italy
facility: IFC CNR-Ospedale Pasquinucci
state: MS
city: Massa
country: Italy
facility: Ospedale SS.Giacomo e Cristoforo
state: MS
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie
state: MT
city: Policoro
country: Italy
facility: Ospedale Civile
state: MT
city: Nuoro
country: Italy
facility: Ospedale San Francesco
state: NU
city: Cefalu'
country: Italy
facility: Fondazione San Raffaele G. Giglio
state: PA
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Fatebenefratelli
state: PA
city: Palermo
country: Italy
facility: A.R.N.A.S. Ospedale Civico e Benfratelli
state: PA
city: Palermo
country: Italy
facility: Ospedale G.F. Ingrassia
state: PA
city: Palermo
country: Italy
facility: Ospedale G.F. Ingrassia
state: PA
city: Palermo
country: Italy
facility: Az. Osp. Villa Sofia CTO (Cardiologia II)
state: PA
city: Palermo
country: Italy
facility: Ospedale V. Cervello
state: PA
city: Palermo
country: Italy
facility: Presidio Ospedaliero Villa Sofia
state: PA
city: Termini Imerese
country: Italy
facility: Ospedale Pubblico S. Cimino
state: PA
city: Camposampiero
country: Italy
facility: Ospedale di Camposampiero
state: PD
city: Cittadella
country: Italy
facility: Ospedale di Cittadella
state: PD
city: Este
country: Italy
facility: Ospedale Generale Provinciale
state: PD
city: Penne
country: Italy
facility: Ospedale Civile San Massimo
state: PE
city: Pescara
country: Italy
facility: Ospedale Civile dello Spirito Santo
state: PE
city: Città di Castello
country: Italy
facility: Ospedale Alta Valle del Tevere
state: PG
city: Foligno
country: Italy
facility: Nuovo Ospedale San Giovanni Battista
state: PG
city: Gubbio
country: Italy
facility: Ospedale Gubbio-Gualdo Tadino
state: PG
city: Passignano sul Trasimeno
country: Italy
facility: Centro Osp.Riabilit.Intensiva (CORI)
state: PG
city: Todi
country: Italy
facility: Presidio Ospedaliero
state: PG
city: Pordenone
country: Italy
facility: Azienda Ospedaliera S. Maria degli Angeli
state: PN
city: San Vito al Tagliamento
country: Italy
facility: Ospedale Civile
state: PN
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
state: PO
city: Fidenza
country: Italy
facility: Ospedale Civile
state: PR
city: Parma
country: Italy
facility: Az. Ospedaliera Universitaria di Parma
state: PR
city: Urbino
country: Italy
facility: Ospedale Santa Maria della Misericordia
state: PU
city: Mede
country: Italy
facility: Ospedale San Martino
state: PV
city: Montescano
country: Italy
facility: Fondazione S.Maugeri Clinica del Lavoro
state: PV
city: Pavia
country: Italy
facility: IRCCS - Fondazione Salvatore Maugeri
state: PV
city: Pavia
country: Italy
facility: Ospedale Policlinico San Matteo IRCCS
state: PV
city: Vigevano
country: Italy
facility: Istituto Clinico Beato Matteo
state: PV
city: Vigevano
country: Italy
facility: Ospedale Civile
state: PV
city: Voghera
country: Italy
facility: Ospedale Civile
state: PV
city: Lagonegro
country: Italy
facility: Ospedale Generale di Zona
state: PZ
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo
state: PZ
city: Venosa
country: Italy
facility: Ospedale San Francesco
state: PZ
city: Cotignola
country: Italy
facility: Villa Maria Cecilia Hospital
state: RA
city: Reggio Calabria
country: Italy
facility: Policlinico Madonna della Consolazione
state: RC
city: Scilla
country: Italy
facility: Ospedale Scillesi D'America
state: RC
city: Scilla
country: Italy
facility: Ospedale Scillesi D'America
state: RC
city: Castelnuovo Ne' Monti
country: Italy
facility: Ospedale Sant'Anna
state: Re
city: Correggio
country: Italy
facility: Ospedale Civile San Sebastiano
state: RE
city: Ragusa
country: Italy
facility: Ospedale Civile
state: RG
city: Ragusa
country: Italy
facility: Ospedale M.P. Arezzo
state: RG
city: Rieti
country: Italy
facility: P.O. San Camillo De Lellis
state: RI
city: Albano Laziale
country: Italy
facility: Ospedali Riuniti Albano-Genzano
state: RM
city: Civitavecchia
country: Italy
facility: Ospedale Civile San Paolo
state: RM
city: Colleferro
country: Italy
facility: Ospedale Generale Zona Parodi Delfino
state: RM
city: Frascati
country: Italy
facility: Ospedale San Sebastiano Martire
state: RM
city: Marino
country: Italy
facility: Ospedale San Giuseppe
state: RM
city: Monterotondo
country: Italy
facility: Ospedale di Monterotondo
state: RM
city: Roma
country: Italy
facility: Campus Biomedico
state: RM
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
state: RM
city: Roma
country: Italy
facility: Ospedale Sant'Eugenio
state: RM
city: Roma
country: Italy
facility: Ospedale C. Forlanini
state: RM
city: Roma
country: Italy
facility: Ospedale San Camillo
state: RM
city: Roma
country: Italy
facility: Ospedale San Camillo
state: RM
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
state: RM
city: Roma
country: Italy
facility: Policlinico Umberto Primo
state: RM
city: Roma
country: Italy
facility: Ospedale San Carlo di Nancy
state: RM
city: Roma
country: Italy
facility: Presidio Ospedaliero Villa Betania
state: RM
city: Roma
country: Italy
facility: Ospedale Generale di Zona "Cristo Re"
state: RM
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli
state: RM
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
state: RM
city: Roma
country: Italy
facility: I.N.R.C.A.
state: RM
city: Roma
country: Italy
facility: Ospedale Santo Spirito
state: RM
city: Subiaco
country: Italy
facility: Ospedale A. Angelucci
state: RM
city: Tivoli
country: Italy
facility: Ospedale San Giovanni Evangelista
state: RM
city: Velletri
country: Italy
facility: Ospedale Civile
state: RM
city: Riccione
country: Italy
facility: Ospedale G. Ceccarini
state: RN
city: Rimini
country: Italy
facility: Ospedale Infermi
state: RN
city: Adria
country: Italy
facility: Ospedale Civile
state: RO
city: Rovigo
country: Italy
facility: Presidio Ospedaliero
state: RO
city: Battipaglia
country: Italy
facility: Presidio Ospedaliero S.Maria della Speranza
state: SA
city: Mercato San Severino
country: Italy
facility: Ospedale G. Fucito
state: SA
city: Nocera Inferiore
country: Italy
facility: Ospedale Civile
state: SA
city: Oliveto Citra
country: Italy
facility: Ospedale San Francesco D'Assisi
state: SA
city: Salerno
country: Italy
facility: A.O. S.Giovanni di Dio e Ruggi di Aragona
state: SA
city: Sapri
country: Italy
facility: Ospedale dell'Immacolata
state: SA
city: Scafati
country: Italy
facility: Ospedale Civile
state: SA
city: Vallo della Lucania
country: Italy
facility: Ospedale San Luca
state: SA
city: Montepulciano
country: Italy
facility: Presidio Ospedaliero Valdichiana Senese
state: SI
city: Poggibonsi
country: Italy
facility: Presidio Ospedaliero
state: SI
city: Siena
country: Italy
facility: Policlinico Santa Maria alle Scotte
state: SI
city: Morbegno
country: Italy
facility: Ospedale Civile
state: SO
city: Sondalo
country: Italy
facility: Ospedale E. Morelli
state: SO
city: Sondrio
country: Italy
facility: Ospedale Civile
state: SO
city: La Spezia
country: Italy
facility: Ospedale S. Andrea
state: SP
city: Sarzana - Loc. Santa Caterina
country: Italy
facility: Ospedale San Bartolomeo
state: SP
city: Siracusa
country: Italy
facility: Azienda Ospedaliera Umberto I
state: SR
city: Sassari
country: Italy
facility: Az. Ospedaliero Universitaria di Sassari
state: SS
city: Thiesi
country: Italy
facility: Ospedale Civile
state: SS
city: Castellaneta
country: Italy
facility: Ospedale Civile
state: TA
city: Martina Franca
country: Italy
facility: Presidio Ospedaliero della Valle D'Itria
state: TA
city: Mottola
country: Italy
facility: Ospedale Umberto I
state: TA
city: Taranto
country: Italy
facility: Ospedale S. Giuseppe Moscati
state: TA
city: Taranto
country: Italy
facility: Ospedale SS. Annunziata
state: TA
city: Teramo
country: Italy
facility: Ospedale Civile G. Mazzini
state: TE
city: Arco
country: Italy
facility: Ospedale Alto Garda e Ledro
state: TN
city: Trento
country: Italy
facility: Casa di Cura Villa Bianca
state: TN
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
state: To
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga
state: TO
city: Pinerolo
country: Italy
facility: Ospedale Civile E. Agnelli
state: TO
city: Susa
country: Italy
facility: Presidio Ospedaliero
state: TO
city: Torino
country: Italy
facility: Ospedale Evangelico Valdese
state: TO
city: Torino
country: Italy
facility: Ospedale Martini
state: TO
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
state: TO
city: Torino
country: Italy
facility: Presidio Ospedaliero Gradenigo
state: TO
city: Castelvetrano
country: Italy
facility: Ospedale Civile Vittorio Emanuele II
state: TP
city: Erice
country: Italy
facility: Ospedale Civile Sant'Antonio Abate
state: TP
city: Mazara del Vallo
country: Italy
facility: Ospedale A. Ajello
state: TP
city: Terni
country: Italy
facility: Azienda USL 4 Terni
state: TR
city: Trieste
country: Italy
facility: Azienda Ospedaliera - Univ. Ospedali Riuniti
state: TS
city: Conegliano Veneto
country: Italy
facility: Ospedale De Gironcoli
state: TV
city: Conegliano Veneto
country: Italy
facility: Ospedale Santa Maria dei Battuti
state: TV
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello
state: TV
city: Palmanova
country: Italy
facility: Ospedale di Ialmicco - Palmanova - Udine
state: UD
city: San Daniele del Friuli
country: Italy
facility: Ospedale S. Antonio
state: UD
city: Tolmezzo
country: Italy
facility: Ospedale Civile Sant'Antonio Abate
state: UD
city: Udine
country: Italy
facility: Santa Maria della Misericordia
state: UD
city: Gallarate
country: Italy
facility: Ospedale S. Antonio Abate
state: VA
city: Saronno
country: Italy
facility: Presidio Ospedaliero
state: VA
city: Somma Lombardo
country: Italy
facility: Ospedale di Circolo A. Bellini
state: VA
city: Tradate
country: Italy
facility: Fondazione S. Maugeri Clinica del Lavoro
state: VA
city: Varese
country: Italy
facility: Azienda Ospedaliera e Universitaria
state: VA
city: Varese
country: Italy
facility: Ospedale del Ponte
state: VA
city: Verbania
country: Italy
facility: Ospedale Castelli
state: VB
city: Dolo
country: Italy
facility: Ospedale Civile
state: VE
city: Mestre
country: Italy
facility: Ospedale Civile Umberto I
state: VE
city: Mirano
country: Italy
facility: Ospedale Civile
state: VE
city: Portogruaro
country: Italy
facility: Ospedale Civile
state: VE
city: Venezia
country: Italy
facility: Ospedali Civili Riuniti
state: VE
city: Noventa Vicentina
country: Italy
facility: Ospedale Civile
state: VI
city: Bovolone
country: Italy
facility: Ospedale Civile San Biagio
state: VR
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: VR
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore
state: VR
city: San Bonifacio
country: Italy
facility: Ospedale G. Fra Castoro
state: VR
city: Verona
country: Italy
facility: Azienda Ospedaliera
state: VR
city: Villafranca di Verona
country: Italy
facility: Ospedale di Villafranca
state: VR
city: Soriano Calabro
country: Italy
facility: Presidio Ospedaliero
state: VV
city: Vibo Valentia
country: Italy
facility: Ospedale Civile G. Jazzolino
state: VV
city: Borgomanero
country: Italy
facility: Ospedale SS. Trinita'
city: Boscotrecase
country: Italy
facility: Ospedale Civile di Boscotrecase
city: Castellammare di Stabia
country: Italy
facility: Opsedale San Leonardo
city: Frattaminore
country: Italy
facility: Ospedale Civile San Giovanni di Dio
city: Giugliano in Campania
country: Italy
facility: Ospedale Generale di Zona
city: Milano
country: Italy
facility: MIOspedale San Raffaele
city: Napoli
country: Italy
facility: AORN Cardarelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Vincenzo Monaldi
city: Napoli
country: Italy
facility: Fondazione Pascale
city: Napoli
country: Italy
facility: Ospedale Domenico Cotugno
city: Napoli
country: Italy
facility: Policlinico Universitario Federico II
city: Nola
country: Italy
facility: Pres.Ospedaliero S. Maria della Pieta'
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria delle Grazie
city: Sorrento
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Veruno
country: Italy
facility: Fondazione Salvatore Maugeri
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
Study officials:
affiliation: Policlinico San Matteo di Pavia
name: Luigi Tavazzi, MD
role: STUDY_CHAIR
affiliation: Consorzio Mario Negri Sud
name: Gianni Tognoni, MD
role: STUDY_CHAIR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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