GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
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
1 other identifier
interventional
1,442
2 countries
114
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Nov 2004
Typical duration for phase_3 atrial-fibrillation
114 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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2006
CompletedFirst Posted
Study publicly available on registry
September 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 20, 2009
April 1, 2009
3.2 years
September 12, 2006
April 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 to first AF recurrence
First recurrence of AF,
time to first AF recurrence
Rate of patients with more than one AF episode,
end of follow-up
Secondary Outcomes (8)
Number of AF episodes
end of fw-up
Number of hospitalizations for CV reasons
end of fw-up
Number of all-cause hospitalizations
end of fw-up
Incidence of thromboembolic events
end of fw-up
Number of patients who die or with non-fatal thromboembolic events
end of fw-up
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
Ospedale Valdichiana Santa Margherita
Cortona, AR, 52040, Italy
Ospedale Cardinal Massaia
Asti, AT, 14100, Italy
Azienda Ospedaliera Giuseppe Moscati
Avellino, AV, 83100, Italy
Ospedale Consorziale Policlinico
Bari, BA, 70124, Italy
Ospedale di Venere
Bari - Carbonara, BA, 70012, Italy
Ospedali Riuniti di Bergamo
Bergamo, BG, 24128, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, 40010, Italy
Ospedale Maggiore
Bologna, BO, 40133, Italy
Ospedale Bellaria
Bologna, BO, 40139, Italy
Casa di Cura Poliambulanza
Brescia, BS, 25122, Italy
Ospedale Civile Mellini
Chiari, BS, 25032, Italy
Ospedlae Generale Regionale
Bolzano, BZ, 39100, Italy
Azienda Ospedaliera G. Brotzu - S. Michele
Cagliari, CA, 09134, Italy
Presidio Ospedaliero Moscati
Aversa, CE, 81031, Italy
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, CE, 81100, Italy
Ospedale Civile Ave Gratia Plena
Piedimonte Matese, CE, 81016, Italy
Ospedale Ave Gratia Plena
San Felice A Cancello, CE, 81027, Italy
Ospedale San Giuseppe e Melorio
Santa Maria Capua Vetere, CE, 81055, Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, CN, 12100, Italy
Ospedale Civile Saluzzo
Saluzzo, CN, 12037, Italy
Ospedlae Maggiore
Crema, CR, 26013, Italy
Istituti Ospitalieri di Cremona
Cremona, CR, 26100, Italy
Ospedale Santissima Annunziata
Cosenza, CS, 87100, Italy
Presidio Ospedaliero Mariano Santo
Cosenza, CS, 87100, Italy
Ospedale San Francesco di Paola
Paola, CS, 87027, Italy
Ospedale Santa Barbara
Rogliano, CS, 87054, Italy
Presidio Ospedaliero San Marco Argentano
San Marco Argentano, CS, 87018, Italy
Ospedale Civile "G. Chidichimo"
Trebisacce, CS, 87075, Italy
Ospedale Garibaldi - Nesima
Catania, CT, 95122, Italy
Ospedale Civile Pugliese
Catanzaro, CZ, 88100, Italy
Ospedale Civile
Lamezia Terme, CZ, 88046, Italy
Azienda Ospedaliera Mater Domini
LocalitĂ Germaneto - Catanzaro, CZ, 88100, Italy
Ospedale G. Basilotta
Nicosia, EN, 94014, Italy
Arcispedale Sant'Anna
Ferrara, FE, 44100, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, FI, 50011, Italy
Nuovo Ospedale San Giovanni di Dio
Florence, FI, 50143, Italy
Ospedali Civili di Sampierdarena
Genova-Sampierdarena, GE, 16149, Italy
Ospedale San Carlo
Genova-Voltri, GE, 16158, Italy
Ospedale Civile San Paolo
Monfalcone, GO, 34072, Italy
Ospedale Civile
Imperia, IM, 18100, Italy
Ospedale Civile San Giovanni di Dio
Crotone, KR, 88900, Italy
Presidio Ospedaliero F. Ferrari
Casarano, LE, 73042, Italy
Ospedale Ignazio Veris Delli Ponti
Scorrano, LE, 73020, Italy
Ospedale Civile Bassa Val di Cecina
Cecina, LI, 57023, Italy
Ospedali Riuniti
Livorno, LI, 57124, Italy
Ospedale del dono Svizzero
Formia, LT, 04023, Italy
Ospedale Civile Campo di Marte
Lucca, LU, 55100, Italy
Ospedale Civile
Milazzo, ME, 98057, Italy
Ospedale Carlo Borella
Giussano, MI, 20034, Italy
Ospedale San Raffaele
Milan, MI, 20132, Italy
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
Multimedica SPA
Sesto San Giovanni, MI, 20099, Italy
Ospedale Policlinico
Modena, MO, 41100, Italy
Nuovo Ospedale Civile di Sassuolo
Sassuolo, MO, 41049, Italy
Ospedale Madonna delle Grazie
Matera, MT, 75100, Italy
Ospedale Civile
Policoro, MT, 75025, Italy
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, PA, 90123, Italy
A.R.N.A.S. Ospedale Civico e Benfratelli
Palermo, PA, 90127, Italy
Ospedale V. Cervello
Palermo, PA, 90146, Italy
Presidio Ospedaliero Villa Sofia
Palermo, PA, 90146, Italy
Ospedale Generale Provinciale
Este, PD, 35042, Italy
Ospedale Civile San Massimo
Penne, PE, 65017, Italy
Ospedale Alta Valle del Tevere
CittĂ di Castello, PG, 06012, Italy
Nuovo Ospedale San Giovanni Battista
Foligno, PG, 06034, Italy
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, PN, 33170, Italy
Ospedale Civile
Fidenza, PR, 43036, Italy
Azienda Ospedaliera San Salvatore
Pesaro, PU, 61100, Italy
IRCCS - Fondazione Salvatore Maugeri
Pavia, PV, 27100, Italy
Ospedale Policlinico San Matteo IRCCS
Pavia, PV, 27100, Italy
Csa di Cura Villa Maria Cecilia
Cotignola, RA, 48010, Italy
Ospedale Santa Maria degli Ungheresi
Polistena, RC, 89024, Italy
Policlinico Madonna della Consolazione
Reggio Calabria, RC, 89124, Italy
Ospedale Scillesi D'America
Scilla, RC, 89024, Italy
Ospedali Riuniti Albano-Genzano
Albano Laziale, RM, 00041, Italy
Ospedale San Filippo Neri
Roma, RM, 00135, Italy
CTO
Roma, RM, 00145, Italy
Ospedale San Giovanni
Roma, RM, 00148, Italy
Ospedale San Camillo
Roma, RM, 00149, Italy
Ospedale San Camillo
Roma, RM, 00152, Italy
Ospedale Sant'Andrea
Roma, RM, 00189, Italy
Ospedale Infermi
Rimini, RN, 47900, Italy
Casa di Cura Madonna della Salute
Porto Viro, RO, 45014, Italy
Presidio Ospedaliero
Rovigo, RO, 45100, Italy
Ospedale G. Fucito
Mercato San Severino, SA, 84085, Italy
Ospedale San Luca
Vallo della Lucania, SA, 84078, Italy
Ospedale San Bartolomeo
Sarzana - Loc. Santa Caterina, SP, 19038, Italy
Ospedale Santa Corona
Pietra Ligure, SV, 17027, Italy
Casa di Cura Villa Verde
Taranto, TA, 74100, Italy
Ospedale SS. Annunziata
Taranto, TA, 74100, Italy
Ospedale Civile G. Mazzini
Teramo, TE, 64100, Italy
Ospedale di Cles
Cles, TN, 38023, Italy
Casa di Cura Villa Bianca
Trento, TN, 38100, Italy
Ospedale Evangelico Valdese
Torino, TO, 10125, Italy
Azienda USL 4 Terni
Terni, TR, 05100, Italy
Ospedale Santa Chiara
Trento, TR, 38100, Italy
Azienda Servizi Sanitari N. 1 Triestina
Trieste, TS, 34142, 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 di Ialmicco - Palmanova - Udine
Palmanova, UD, 33057, Italy
Ospedale S. Antonio
San Daniele del Friuli, UD, 33038, Italy
Santa Maria della Misericordia
Udine, UD, 33100, Italy
Azienda Ospedaliera e Universitaria
Varese, VA, 21100, Italy
Ospedale Civile Umberto I
Mestre, VE, 30171, Italy
Ospedale Civile
Mirano, VE, 30035, Italy
Ospedale Civile San Biagio
Bovolone, VR, 37051, Italy
Ospedale G. Fra Castoro
San Bonifacio, VR, 37047, Italy
Presidio Ospedaliero
Soriano Calabro, VV, 89831, Italy
Ospedale Civile G. Jazzolino
Vibo Valentia, VV, 89900, Italy
Ospedale Generale di Zona
Giugliano in Campania, 80014, Italy
Azienda Ospedaliera Vincenzo Monaldi
Napoli, 80131, Italy
Policlinico Universitario Federico II
Napoli, 80131, Italy
Ospedale Santa Maria delle Grazie
Pozzuoli, 80078, Italy
Cardiocentro Ticino
Lugano, 6900, Switzerland
Related Publications (6)
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.
PMID: 16645357BACKGROUNDGISSI-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.
PMID: 19369667BACKGROUNDDisertori 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.
PMID: 23586654DERIVEDStaszewsky 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.
PMID: 21926261DERIVEDDisertori 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.
PMID: 21835301DERIVEDDisertori 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.
PMID: 20435196DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marcello Disertori, MD
Gruppo di Ricerca GISSI
- STUDY CHAIR
Roberto Latini, MD
Gruppo di Ricerca GISSI
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
Study Record Dates
First Submitted
September 12, 2006
First Posted
September 14, 2006
Study Start
November 1, 2004
Primary Completion
January 1, 2008
Study Completion
March 1, 2008
Last Updated
April 20, 2009
Record last verified: 2009-04