Back to resultsGISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valsartan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation,atrial remodeling,dysrhythmias,valsartan
Eligibility Criteria
Inclusion Criteria:
- Male or female patients >=40 years of age
- Sinus rhythm
- At least two ECG documented episodes of symptomatic AF in the previous 6 months or After a successful cardioversion for AF performed between 14 days and 48 hours before randomization
At least one of the following underlying cardiovascular diseases/comorbidities:
- heart failure/documented history of LV dysfunction (defined as an EF <40%)
- history of hypertension >=6 months with/without LVH
- Type II diabetes mellitus
- documented history of stroke or peripheral vascular disease
- documented history of coronary artery disease
- lone atrial fibrillation with documented LA dilation (LA diameter >=45 mm for men and >=40 mm for women)
- Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
- Need for a continuous treatment with ARBs for any clinical reasons
- Contraindications or known hypersensitivity to ARBs
- Persistent standing systolic blood pressure < 110 mmHg
- Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
- Clinically significant valvular etiologies
- Thyroid dysfunction
- Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
- Planned cardiac surgery, expected to be performed within 3 months
- Serum creatinine level above 2.5 mg/dL
- 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
- Currently decompensated heart failure
Sites / Locations
- Ospedale Valdichiana Santa Margherita
- Ospedale Cardinal Massaia
- Azienda Ospedaliera Giuseppe Moscati
- Ospedale di Venere
- Ospedale Consorziale Policlinico
- Ospedali Riuniti di Bergamo
- Ospedale di Bentivoglio
- Ospedale Maggiore
- Ospedale Bellaria
- Casa di Cura Poliambulanza
- Ospedale Civile Mellini
- Ospedlae Generale Regionale
- Azienda Ospedaliera G. Brotzu - S. Michele
- Presidio Ospedaliero Moscati
- Azienda Ospedaliera Sant'Anna e San Sebastiano
- Ospedale Civile Ave Gratia Plena
- Ospedale Ave Gratia Plena
- Ospedale San Giuseppe e Melorio
- Azienda Ospedaliera Santa Croce e Carle
- Ospedale Civile Saluzzo
- Ospedlae Maggiore
- Istituti Ospitalieri di Cremona
- Ospedale Santissima Annunziata
- Presidio Ospedaliero Mariano Santo
- Ospedale San Francesco di Paola
- Ospedale Santa Barbara
- Presidio Ospedaliero San Marco Argentano
- Ospedale Civile "G. Chidichimo"
- Ospedale Garibaldi - Nesima
- Ospedale Civile Pugliese
- Ospedale Civile
- Azienda Ospedaliera Mater Domini
- Ospedale G. Basilotta
- Arcispedale Sant'Anna
- Ospedale Santa Maria Annunziata
- Nuovo Ospedale San Giovanni di Dio
- Ospedali Civili di Sampierdarena
- Ospedale San Carlo
- Ospedale Civile San Paolo
- Ospedale Civile
- Ospedale Civile San Giovanni di Dio
- Presidio Ospedaliero F. Ferrari
- Ospedale Ignazio Veris Delli Ponti
- Ospedale Civile Bassa Val di Cecina
- Ospedali Riuniti
- Ospedale del dono Svizzero
- Ospedale Civile Campo di Marte
- Ospedale Civile
- Ospedale Carlo Borella
- Ospedale San Raffaele
- Istituto Clinico Humanitas
- Multimedica SPA
- Ospedale Policlinico
- Nuovo Ospedale Civile di Sassuolo
- Ospedale Madonna delle Grazie
- Ospedale Civile
- Ospedale Buccheri La Ferla Fatebenefratelli
- A.R.N.A.S. Ospedale Civico e Benfratelli
- Ospedale V. Cervello
- Presidio Ospedaliero Villa Sofia
- Ospedale Generale Provinciale
- Ospedale Civile San Massimo
- Ospedale Alta Valle del Tevere
- Nuovo Ospedale San Giovanni Battista
- Azienda Ospedaliera S. Maria degli Angeli
- Ospedale Civile
- Azienda Ospedaliera San Salvatore
- IRCCS - Fondazione Salvatore Maugeri
- Ospedale Policlinico San Matteo IRCCS
- Csa di Cura Villa Maria Cecilia
- Ospedale Santa Maria degli Ungheresi
- Policlinico Madonna della Consolazione
- Ospedale Scillesi D'America
- Ospedali Riuniti Albano-Genzano
- Ospedale San Filippo Neri
- CTO
- Ospedale San Giovanni
- Ospedale San Camillo
- Ospedale San Camillo
- Ospedale Sant'Andrea
- Ospedale Infermi
- Casa di Cura Madonna della Salute
- Presidio Ospedaliero
- Ospedale G. Fucito
- Ospedale San Luca
- Ospedale San Bartolomeo
- Ospedale Santa Corona
- Casa di Cura Villa Verde
- Ospedale SS. Annunziata
- Ospedale Civile G. Mazzini
- Ospedale di Cles
- Casa di Cura Villa Bianca
- Ospedale Evangelico Valdese
- Azienda USL 4 Terni
- Ospedale Santa Chiara
- Azienda Servizi Sanitari N. 1 Triestina
- Azienda Ospedaliera - Univ. Ospedali Riuniti
- Ospedale De Gironcoli
- Ospedale Santa Maria dei Battuti
- Ospedale di Ialmicco - Palmanova - Udine
- Ospedale S. Antonio
- Santa Maria della Misericordia
- Azienda Ospedaliera e Universitaria
- Ospedale Civile Umberto I
- Ospedale Civile
- Ospedale Civile San Biagio
- Ospedale G. Fra Castoro
- Presidio Ospedaliero
- Ospedale Civile G. Jazzolino
- Ospedale Generale di Zona
- Azienda Ospedaliera Vincenzo Monaldi
- Policlinico Universitario Federico II
- Ospedale Santa Maria delle Grazie
- Cardiocentro Ticino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:
First recurrence of AF,
Rate of patients with more than one AF episode,
Secondary Outcome Measures
Number of AF episodes
Number of hospitalizations for CV reasons
Number of all-cause hospitalizations
Incidence of thromboembolic events
Number of patients who die or with non-fatal thromboembolic events
Number of patients in sinus rhythm at the time of each study visit
Number of patients in sinus rhythm who did not have any prior AF recurrence during the study
Duration and characteristics (ventricular rate) of the first recurrence of AF.
Full Information
NCT ID
NCT00376272
First Posted
September 12, 2006
Last Updated
April 17, 2009
Sponsor
Gruppo di Ricerca GISSI
1. Study Identification
Unique Protocol Identification Number
NCT00376272
Brief Title
GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Official Title
Randomized, Prospective, Parallel Group, Placebo-Controlled, Multi-Center Study on the Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gruppo di Ricerca GISSI
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study purpose The purpose of the study is to show that the addition of valsartan on top of established therapies can reduce the recurrence of atrial fibrillation in patients with a history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities.
Primary objective To demonstrate that, in patients with history of recent atrial fibrillation treated with the best recommended therapies, the addition of valsartan 320 mg is superior to placebo in reducing atrial fibrillation recurrence.
Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo controlled study. Patients with a history of atrial fibrillation will be centrally randomized in a 1:1 ratio to receive either valsartan or placebo.
GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. The enrollment period will last 12 months. The patients will be followed up for 12 months from study entry
All prescribed treatments for AF or for the underlying cardiovascular diseases, including ACE-inhibitors, amiodarone and betablockers, will be allowed:
patients should be on a stable treatment for at least one month
the current guideline for hypertension treatment should be applied
patients should not be started on ARBs during the study
Detailed Description
The protocol is sponsored by an independent organization and partially supported by Novartis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation,atrial remodeling,dysrhythmias,valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:
Time Frame
Time to first AF recurrence
Title
First recurrence of AF,
Time Frame
time to first AF recurrence
Title
Rate of patients with more than one AF episode,
Time Frame
end of follow-up
Secondary Outcome Measure Information:
Title
Number of AF episodes
Time Frame
end of fw-up
Title
Number of hospitalizations for CV reasons
Time Frame
end of fw-up
Title
Number of all-cause hospitalizations
Time Frame
end of fw-up
Title
Incidence of thromboembolic events
Time Frame
end of fw-up
Title
Number of patients who die or with non-fatal thromboembolic events
Time Frame
end of fw-up
Title
Number of patients in sinus rhythm at the time of each study visit
Time Frame
end of fw-up
Title
Number of patients in sinus rhythm who did not have any prior AF recurrence during the study
Time Frame
end of fw-up
Title
Duration and characteristics (ventricular rate) of the first recurrence of AF.
Time Frame
end of fw-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients >=40 years of age
Sinus rhythm
At least two ECG documented episodes of symptomatic AF in the previous 6 months or After a successful cardioversion for AF performed between 14 days and 48 hours before randomization
At least one of the following underlying cardiovascular diseases/comorbidities:
heart failure/documented history of LV dysfunction (defined as an EF <40%)
history of hypertension >=6 months with/without LVH
Type II diabetes mellitus
documented history of stroke or peripheral vascular disease
documented history of coronary artery disease
lone atrial fibrillation with documented LA dilation (LA diameter >=45 mm for men and >=40 mm for women)
Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
Need for a continuous treatment with ARBs for any clinical reasons
Contraindications or known hypersensitivity to ARBs
Persistent standing systolic blood pressure < 110 mmHg
Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
Clinically significant valvular etiologies
Thyroid dysfunction
Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
Planned cardiac surgery, expected to be performed within 3 months
Serum creatinine level above 2.5 mg/dL
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
Currently decompensated heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcello Disertori, MD
Organizational Affiliation
Gruppo di Ricerca GISSI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roberto Latini, MD
Organizational Affiliation
Gruppo di Ricerca GISSI
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Valdichiana Santa Margherita
City
Cortona
State/Province
AR
ZIP/Postal Code
52040
Country
Italy
Facility Name
Ospedale Cardinal Massaia
City
Asti
State/Province
AT
ZIP/Postal Code
14100
Country
Italy
Facility Name
Azienda Ospedaliera Giuseppe Moscati
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Ospedale di Venere
City
Bari - Carbonara
State/Province
BA
ZIP/Postal Code
70012
Country
Italy
Facility Name
Ospedale Consorziale Policlinico
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale di Bentivoglio
City
Bentivoglio
State/Province
BO
ZIP/Postal Code
40010
Country
Italy
Facility Name
Ospedale Maggiore
City
Bologna
State/Province
BO
ZIP/Postal Code
40133
Country
Italy
Facility Name
Ospedale Bellaria
City
Bologna
State/Province
BO
ZIP/Postal Code
40139
Country
Italy
Facility Name
Casa di Cura Poliambulanza
City
Brescia
State/Province
BS
ZIP/Postal Code
25122
Country
Italy
Facility Name
Ospedale Civile Mellini
City
Chiari
State/Province
BS
ZIP/Postal Code
25032
Country
Italy
Facility Name
Ospedlae Generale Regionale
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy
Facility Name
Azienda Ospedaliera G. Brotzu - S. Michele
City
Cagliari
State/Province
CA
ZIP/Postal Code
09134
Country
Italy
Facility Name
Presidio Ospedaliero Moscati
City
Aversa
State/Province
CE
ZIP/Postal Code
81031
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Anna e San Sebastiano
City
Caserta
State/Province
CE
ZIP/Postal Code
81100
Country
Italy
Facility Name
Ospedale Civile Ave Gratia Plena
City
Piedimonte Matese
State/Province
CE
ZIP/Postal Code
81016
Country
Italy
Facility Name
Ospedale Ave Gratia Plena
City
San Felice a Cancello
State/Province
CE
ZIP/Postal Code
81027
Country
Italy
Facility Name
Ospedale San Giuseppe e Melorio
City
Santa Maria Capua Vetere
State/Province
CE
ZIP/Postal Code
81055
Country
Italy
Facility Name
Azienda Ospedaliera Santa Croce e Carle
City
Cuneo
State/Province
CN
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale Civile Saluzzo
City
Saluzzo
State/Province
CN
ZIP/Postal Code
12037
Country
Italy
Facility Name
Ospedlae Maggiore
City
Crema
State/Province
CR
ZIP/Postal Code
26013
Country
Italy
Facility Name
Istituti Ospitalieri di Cremona
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale Santissima Annunziata
City
Cosenza
State/Province
CS
ZIP/Postal Code
87100
Country
Italy
Facility Name
Presidio Ospedaliero Mariano Santo
City
Cosenza
State/Province
CS
ZIP/Postal Code
87100
Country
Italy
Facility Name
Ospedale San Francesco di Paola
City
Paola
State/Province
CS
ZIP/Postal Code
87027
Country
Italy
Facility Name
Ospedale Santa Barbara
City
Rogliano
State/Province
CS
ZIP/Postal Code
87054
Country
Italy
Facility Name
Presidio Ospedaliero San Marco Argentano
City
San Marco Argentano
State/Province
CS
ZIP/Postal Code
87018
Country
Italy
Facility Name
Ospedale Civile "G. Chidichimo"
City
Trebisacce
State/Province
CS
ZIP/Postal Code
87075
Country
Italy
Facility Name
Ospedale Garibaldi - Nesima
City
Catania
State/Province
CT
ZIP/Postal Code
95122
Country
Italy
Facility Name
Ospedale Civile Pugliese
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale Civile
City
Lamezia Terme
State/Province
CZ
ZIP/Postal Code
88046
Country
Italy
Facility Name
Azienda Ospedaliera Mater Domini
City
Località Germaneto - Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale G. Basilotta
City
Nicosia
State/Province
EN
ZIP/Postal Code
94014
Country
Italy
Facility Name
Arcispedale Sant'Anna
City
Ferrara
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Ospedale Santa Maria Annunziata
City
Bagno a Ripoli
State/Province
FI
ZIP/Postal Code
50011
Country
Italy
Facility Name
Nuovo Ospedale San Giovanni di Dio
City
Firenze
State/Province
FI
ZIP/Postal Code
50143
Country
Italy
Facility Name
Ospedali Civili di Sampierdarena
City
Genova-Sampierdarena
State/Province
GE
ZIP/Postal Code
16149
Country
Italy
Facility Name
Ospedale San Carlo
City
Genova-Voltri
State/Province
GE
ZIP/Postal Code
16158
Country
Italy
Facility Name
Ospedale Civile San Paolo
City
Monfalcone
State/Province
GO
ZIP/Postal Code
34072
Country
Italy
Facility Name
Ospedale Civile
City
Imperia
State/Province
IM
ZIP/Postal Code
18100
Country
Italy
Facility Name
Ospedale Civile San Giovanni di Dio
City
Crotone
State/Province
KR
ZIP/Postal Code
88900
Country
Italy
Facility Name
Presidio Ospedaliero F. Ferrari
City
Casarano
State/Province
LE
ZIP/Postal Code
73042
Country
Italy
Facility Name
Ospedale Ignazio Veris Delli Ponti
City
Scorrano
State/Province
LE
ZIP/Postal Code
73020
Country
Italy
Facility Name
Ospedale Civile Bassa Val di Cecina
City
Cecina
State/Province
LI
ZIP/Postal Code
57023
Country
Italy
Facility Name
Ospedali Riuniti
City
Livorno
State/Province
LI
ZIP/Postal Code
57124
Country
Italy
Facility Name
Ospedale del dono Svizzero
City
Formia
State/Province
LT
ZIP/Postal Code
04023
Country
Italy
Facility Name
Ospedale Civile Campo di Marte
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Facility Name
Ospedale Civile
City
Milazzo
State/Province
ME
ZIP/Postal Code
98057
Country
Italy
Facility Name
Ospedale Carlo Borella
City
Giussano
State/Province
MI
ZIP/Postal Code
20034
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Multimedica SPA
City
Sesto San Giovanni
State/Province
MI
ZIP/Postal Code
20099
Country
Italy
Facility Name
Ospedale Policlinico
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Nuovo Ospedale Civile di Sassuolo
City
Sassuolo
State/Province
MO
ZIP/Postal Code
41049
Country
Italy
Facility Name
Ospedale Madonna delle Grazie
City
Matera
State/Province
MT
ZIP/Postal Code
75100
Country
Italy
Facility Name
Ospedale Civile
City
Policoro
State/Province
MT
ZIP/Postal Code
75025
Country
Italy
Facility Name
Ospedale Buccheri La Ferla Fatebenefratelli
City
Palermo
State/Province
PA
ZIP/Postal Code
90123
Country
Italy
Facility Name
A.R.N.A.S. Ospedale Civico e Benfratelli
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Ospedale V. Cervello
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Presidio Ospedaliero Villa Sofia
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale Generale Provinciale
City
Este
State/Province
PD
ZIP/Postal Code
35042
Country
Italy
Facility Name
Ospedale Civile San Massimo
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Ospedale Alta Valle del Tevere
City
Città di Castello
State/Province
PG
ZIP/Postal Code
06012
Country
Italy
Facility Name
Nuovo Ospedale San Giovanni Battista
City
Foligno
State/Province
PG
ZIP/Postal Code
06034
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria degli Angeli
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale Civile
City
Fidenza
State/Province
PR
ZIP/Postal Code
43036
Country
Italy
Facility Name
Azienda Ospedaliera San Salvatore
City
Pesaro
State/Province
PU
ZIP/Postal Code
61100
Country
Italy
Facility Name
IRCCS - Fondazione Salvatore Maugeri
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Policlinico San Matteo IRCCS
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Csa di Cura Villa Maria Cecilia
City
Cotignola
State/Province
RA
ZIP/Postal Code
48010
Country
Italy
Facility Name
Ospedale Santa Maria degli Ungheresi
City
Polistena
State/Province
RC
ZIP/Postal Code
89024
Country
Italy
Facility Name
Policlinico Madonna della Consolazione
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89124
Country
Italy
Facility Name
Ospedale Scillesi D'America
City
Scilla
State/Province
RC
ZIP/Postal Code
89024
Country
Italy
Facility Name
Ospedali Riuniti Albano-Genzano
City
Albano Laziale
State/Province
RM
ZIP/Postal Code
00041
Country
Italy
Facility Name
Ospedale San Filippo Neri
City
Roma
State/Province
RM
ZIP/Postal Code
00135
Country
Italy
Facility Name
CTO
City
Roma
State/Province
RM
ZIP/Postal Code
00145
Country
Italy
Facility Name
Ospedale San Giovanni
City
Roma
State/Province
RM
ZIP/Postal Code
00148
Country
Italy
Facility Name
Ospedale San Camillo
City
Roma
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Facility Name
Ospedale San Camillo
City
Roma
State/Province
RM
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale Sant'Andrea
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
Ospedale Infermi
City
Rimini
State/Province
RN
ZIP/Postal Code
47900
Country
Italy
Facility Name
Casa di Cura Madonna della Salute
City
Porto Viro
State/Province
RO
ZIP/Postal Code
45014
Country
Italy
Facility Name
Presidio Ospedaliero
City
Rovigo
State/Province
RO
ZIP/Postal Code
45100
Country
Italy
Facility Name
Ospedale G. Fucito
City
Mercato San Severino
State/Province
SA
ZIP/Postal Code
84085
Country
Italy
Facility Name
Ospedale San Luca
City
Vallo della Lucania
State/Province
SA
ZIP/Postal Code
84078
Country
Italy
Facility Name
Ospedale San Bartolomeo
City
Sarzana - Loc. Santa Caterina
State/Province
SP
ZIP/Postal Code
19038
Country
Italy
Facility Name
Ospedale Santa Corona
City
Pietra Ligure
State/Province
SV
ZIP/Postal Code
17027
Country
Italy
Facility Name
Casa di Cura Villa Verde
City
Taranto
State/Province
TA
ZIP/Postal Code
74100
Country
Italy
Facility Name
Ospedale SS. Annunziata
City
Taranto
State/Province
TA
ZIP/Postal Code
74100
Country
Italy
Facility Name
Ospedale Civile G. Mazzini
City
Teramo
State/Province
TE
ZIP/Postal Code
64100
Country
Italy
Facility Name
Ospedale di Cles
City
Cles
State/Province
TN
ZIP/Postal Code
38023
Country
Italy
Facility Name
Casa di Cura Villa Bianca
City
Trento
State/Province
TN
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale Evangelico Valdese
City
Torino
State/Province
TO
ZIP/Postal Code
10125
Country
Italy
Facility Name
Azienda USL 4 Terni
City
Terni
State/Province
TR
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale Santa Chiara
City
Trento
State/Province
TR
ZIP/Postal Code
38100
Country
Italy
Facility Name
Azienda Servizi Sanitari N. 1 Triestina
City
Trieste
State/Province
TS
ZIP/Postal Code
34142
Country
Italy
Facility Name
Azienda Ospedaliera - Univ. Ospedali Riuniti
City
Trieste
State/Province
TS
ZIP/Postal Code
34149
Country
Italy
Facility Name
Ospedale De Gironcoli
City
Conegliano Veneto
State/Province
TV
ZIP/Postal Code
31015
Country
Italy
Facility Name
Ospedale Santa Maria dei Battuti
City
Conegliano Veneto
State/Province
TV
ZIP/Postal Code
31015
Country
Italy
Facility Name
Ospedale di Ialmicco - Palmanova - Udine
City
Palmanova
State/Province
UD
ZIP/Postal Code
33057
Country
Italy
Facility Name
Ospedale S. Antonio
City
San Daniele del Friuli
State/Province
UD
ZIP/Postal Code
33038
Country
Italy
Facility Name
Santa Maria della Misericordia
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
Facility Name
Azienda Ospedaliera e Universitaria
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale Civile Umberto I
City
Mestre
State/Province
VE
ZIP/Postal Code
30171
Country
Italy
Facility Name
Ospedale Civile
City
Mirano
State/Province
VE
ZIP/Postal Code
30035
Country
Italy
Facility Name
Ospedale Civile San Biagio
City
Bovolone
State/Province
VR
ZIP/Postal Code
37051
Country
Italy
Facility Name
Ospedale G. Fra Castoro
City
San Bonifacio
State/Province
VR
ZIP/Postal Code
37047
Country
Italy
Facility Name
Presidio Ospedaliero
City
Soriano Calabro
State/Province
VV
ZIP/Postal Code
89831
Country
Italy
Facility Name
Ospedale Civile G. Jazzolino
City
Vibo Valentia
State/Province
VV
ZIP/Postal Code
89900
Country
Italy
Facility Name
Ospedale Generale di Zona
City
Giugliano in Campania
ZIP/Postal Code
80014
Country
Italy
Facility Name
Azienda Ospedaliera Vincenzo Monaldi
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Santa Maria delle Grazie
City
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16645357
Citation
Disertori M, Latini R, Maggioni AP, Delise P, Di Pasquale G, Franzosi MG, Staszewsky L, Tognoni G; GISSI-AF Investigators. Rationale and design of the GISSI-Atrial Fibrillation Trial: a randomized, prospective, multicentre study on the use of valsartan, an angiotensin II AT1-receptor blocker, in the prevention of atrial fibrillation recurrence. J Cardiovasc Med (Hagerstown). 2006 Jan;7(1):29-38. doi: 10.2459/01.JCM.0000199778.85343.08.
Results Reference
background
PubMed Identifier
19369667
Citation
GISSI-AF Investigators; Disertori M, Latini R, Barlera S, Franzosi MG, Staszewsky L, Maggioni AP, Lucci D, Di Pasquale G, Tognoni G. Valsartan for prevention of recurrent atrial fibrillation. N Engl J Med. 2009 Apr 16;360(16):1606-17. doi: 10.1056/NEJMoa0805710. Erratum In: N Engl J Med. 2009 May 28;360(22):2379.
Results Reference
background
PubMed Identifier
23586654
Citation
Disertori M, Franzosi MG, Barlera S, Cosmi F, Quintarelli S, Favero C, Cappellini G, Fabbri G, Maggioni AP, Staszewsky L, Moroni LA, Latini R; GISSI-AF investigators. Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: data from the GISSI-AF trial. BMC Cardiovasc Disord. 2013 Apr 15;13:28. doi: 10.1186/1471-2261-13-28.
Results Reference
derived
PubMed Identifier
21926261
Citation
Staszewsky L, Wong M, Masson S, Raimondi E, Gramenzi S, Proietti G, Bicego D, Emanuelli C, Pulitano G, Taddei F, Nicolis EB, Correale E, Fabbri G, Bertocchi F, Franzosi MG, Maggioni AP, Tognoni G, Disertori M, Latini R; GISSI-AF Investigators. Left atrial remodeling and response to valsartan in the prevention of recurrent atrial fibrillation: the GISSI-AF echocardiographic substudy. Circ Cardiovasc Imaging. 2011 Nov;4(6):721-8. doi: 10.1161/CIRCIMAGING.111.965954. Epub 2011 Sep 16.
Results Reference
derived
PubMed Identifier
21835301
Citation
Disertori M, Lombardi F, Barlera S, Maggioni AP, Favero C, Franzosi MG, Lucci D, Staszewsky L, Fabbri G, Quintarelli S, Bianconi L, Latini R. Clinical characteristics of patients with asymptomatic recurrences of atrial fibrillation in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation (GISSI-AF) trial. Am Heart J. 2011 Aug;162(2):382-9. doi: 10.1016/j.ahj.2011.05.008. Epub 2011 Jul 7.
Results Reference
derived
PubMed Identifier
20435196
Citation
Disertori M, Lombardi F, Barlera S, Latini R, Maggioni AP, Zeni P, Di Pasquale G, Cosmi F, Franzosi MG; GISSI-AF Investigators. Clinical predictors of atrial fibrillation recurrence in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation (GISSI-AF) trial. Am Heart J. 2010 May;159(5):857-63. doi: 10.1016/j.ahj.2010.02.016.
Results Reference
derived
Links:
URL
http://www.anmco.it
Description
Related Info
URL
http://www.gissi.org
Description
Related Info
Learn more about this trial
GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
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