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GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Information source: Gruppo di Ricerca GISSI
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Valsartan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gruppo di Ricerca GISSI

Official(s) and/or principal investigator(s):
Marcello Disertori, MD, Study Chair, Affiliation: Gruppo di Ricerca GISSI
Roberto Latini, MD, Study Chair, Affiliation: Gruppo di Ricerca GISSI


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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:

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.

Detailed description: The protocol is sponsored by an independent organization and partially supported by Novartis


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Male or female patients >=40 years of age 2. Sinus rhythm 3. 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 4. 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) 5. Written informed consent to participate in the study prior to any study procedures Exclusion Criteria: 1. Need for a continuous treatment with ARBs for any clinical reasons 2. Contraindications or known hypersensitivity to ARBs 3. Persistent standing systolic blood pressure < 110 mmHg 4. Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention 5. Clinically significant valvular etiologies 6. Thyroid dysfunction 7. Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment 8. Planned cardiac surgery, expected to be performed within 3 months 9. Serum creatinine level above 2. 5 mg/dL 10. Significant liver disease 11. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception 12. 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 13. Presence of any non-cardiac disease (e. g. cancer) that is likely to significantly shorten life expectancy 14. Treatment with any investigational agent within 1 month before randomization 15. Currently decompensated heart failure

Locations and Contacts

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

Ospedale Valdichiana Santa Margherita, Cortona, AR 52040, Italy

Ospedale Cardinal Massaia, Asti, AT 14100, Italy

Azienda Ospedaliera Giuseppe Moscati, Avellino, AV 83100, Italy

Ospedale di Venere, Bari - Carbonara, BA 70012, Italy

Ospedale Consorziale Policlinico, Bari, BA 70124, Italy

Ospedali Riuniti di Bergamo, Bergamo, BG 24128, Italy

Ospedale di Bentivoglio, Bentivoglio, BO 40010, Italy

Ospedale Bellaria, Bologna, BO 40139, Italy

Ospedale Maggiore, Bologna, BO 40133, 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, Località 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, Firenze, 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, Milano, 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

A.R.N.A.S. Ospedale Civico e Benfratelli, Palermo, PA 90127, Italy

Ospedale Buccheri La Ferla Fatebenefratelli, Palermo, PA 90123, 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, Città 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

CTO, Roma, RM 00145, Italy

Ospedale San Camillo, Roma, RM 00152, Italy

Ospedale San Camillo, Roma, RM 00149, Italy

Ospedale San Filippo Neri, Roma, RM 00135, Italy

Ospedale San Giovanni, Roma, RM 00148, 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 Ospedaliera - Univ. Ospedali Riuniti, Trieste, TS 34149, Italy

Azienda Servizi Sanitari N. 1 Triestina, Trieste, TS 34142, 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

Additional Information

Related publications:

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.

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.

Starting date: November 2004
Last updated: April 17, 2009

Page last updated: August 23, 2015

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