GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
- Registration Number
- NCT00376272
- Lead Sponsor
- Gruppo di Ricerca GISSI
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1442
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Valsartan - 2 Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Number of patients in sinus rhythm at the time of each study visit end of fw-up Number of patients in sinus rhythm who did not have any prior AF recurrence during the study end of fw-up Duration and characteristics (ventricular rate) of the first recurrence of AF. end of fw-up
Trial Locations
- Locations (107)
CTO
🇮🇹Roma, RM, Italy
Ospedale Civile Saluzzo
🇮🇹Saluzzo, CN, Italy
Ospedale Civile G. Mazzini
🇮🇹Teramo, TE, Italy
Ospedale SS. Annunziata
🇮🇹Taranto, TA, Italy
Casa di Cura Villa Verde
🇮🇹Taranto, TA, Italy
Azienda USL 4 Terni
🇮🇹Terni, TR, Italy
Ospedale San Giovanni
🇮🇹Roma, RM, Italy
Ospedale Sant'Andrea
🇮🇹Roma, RM, Italy
Ospedale di Cles
🇮🇹Cles, TN, Italy
Ospedale Evangelico Valdese
🇮🇹Torino, TO, Italy
Ospedale De Gironcoli
🇮🇹Conegliano Veneto, TV, Italy
Azienda Servizi Sanitari N. 1 Triestina
🇮🇹Trieste, TS, Italy
Ospedale Santa Maria dei Battuti
🇮🇹Conegliano Veneto, TV, Italy
Policlinico Universitario Federico II
🇮🇹Napoli, Italy
Ospedale Civile Pugliese
🇮🇹Catanzaro, CZ, Italy
Ospedale Civile San Giovanni di Dio
🇮🇹Crotone, KR, Italy
Policlinico Madonna della Consolazione
🇮🇹Reggio Calabria, RC, Italy
Ospedali Riuniti Albano-Genzano
🇮🇹Albano Laziale, RM, Italy
Presidio Ospedaliero
🇮🇹Soriano Calabro, VV, Italy
Ospedale Civile
🇮🇹Mirano, VE, Italy
Arcispedale Sant'Anna
🇮🇹Ferrara, FE, Italy
Presidio Ospedaliero F. Ferrari
🇮🇹Casarano, LE, Italy
Ospedale di Ialmicco - Palmanova - Udine
🇮🇹Palmanova, UD, Italy
Ospedale S. Antonio
🇮🇹San Daniele del Friuli, UD, Italy
Ospedale Civile Umberto I
🇮🇹Mestre, VE, Italy
Azienda Ospedaliera Vincenzo Monaldi
🇮🇹Napoli, Italy
Ospedale Santa Maria delle Grazie
🇮🇹Pozzuoli, Italy
Ospedale Ave Gratia Plena
🇮🇹San Felice a Cancello, CE, Italy
Ospedale Civile Ave Gratia Plena
🇮🇹Piedimonte Matese, CE, Italy
Ospedale Santissima Annunziata
🇮🇹Cosenza, CS, Italy
Ospedale San Francesco di Paola
🇮🇹Paola, CS, Italy
Istituti Ospitalieri di Cremona
🇮🇹Cremona, CR, Italy
Azienda Ospedaliera Mater Domini
🇮🇹Località Germaneto - Catanzaro, CZ, Italy
Ospedale G. Basilotta
🇮🇹Nicosia, EN, Italy
Ospedale Santa Maria Annunziata
🇮🇹Bagno a Ripoli, FI, Italy
Ospedale San Carlo
🇮🇹Genova-Voltri, GE, Italy
Ospedale Civile San Paolo
🇮🇹Monfalcone, GO, Italy
Ospedale Civile Bassa Val di Cecina
🇮🇹Cecina, LI, Italy
Ospedali Riuniti
🇮🇹Livorno, LI, Italy
Ospedale del dono Svizzero
🇮🇹Formia, LT, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, MI, Italy
Ospedale Carlo Borella
🇮🇹Giussano, MI, Italy
Ospedale San Raffaele
🇮🇹Milano, MI, Italy
Nuovo Ospedale Civile di Sassuolo
🇮🇹Sassuolo, MO, Italy
Ospedale Madonna delle Grazie
🇮🇹Matera, MT, Italy
Multimedica SPA
🇮🇹Sesto San Giovanni, MI, Italy
Ospedale Policlinico
🇮🇹Modena, MO, Italy
Ospedale Buccheri La Ferla Fatebenefratelli
🇮🇹Palermo, PA, Italy
A.R.N.A.S. Ospedale Civico e Benfratelli
🇮🇹Palermo, PA, Italy
Ospedale V. Cervello
🇮🇹Palermo, PA, Italy
Ospedale Civile San Massimo
🇮🇹Penne, PE, Italy
Azienda Ospedaliera San Salvatore
🇮🇹Pesaro, PU, Italy
Ospedale Generale Provinciale
🇮🇹Este, PD, Italy
Ospedale Alta Valle del Tevere
🇮🇹Città di Castello, PG, Italy
Presidio Ospedaliero Villa Sofia
🇮🇹Palermo, PA, Italy
Nuovo Ospedale San Giovanni Battista
🇮🇹Foligno, PG, Italy
Azienda Ospedaliera S. Maria degli Angeli
🇮🇹Pordenone, PN, Italy
Ospedale Policlinico San Matteo IRCCS
🇮🇹Pavia, PV, Italy
IRCCS - Fondazione Salvatore Maugeri
🇮🇹Pavia, PV, Italy
Csa di Cura Villa Maria Cecilia
🇮🇹Cotignola, RA, Italy
Ospedale Scillesi D'America
🇮🇹Scilla, RC, Italy
Ospedale Civile G. Jazzolino
🇮🇹Vibo Valentia, VV, Italy
Azienda Ospedaliera G. Brotzu - S. Michele
🇮🇹Cagliari, CA, Italy
Ospedale Santa Barbara
🇮🇹Rogliano, CS, Italy
Ospedale Civile Mellini
🇮🇹Chiari, BS, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, BG, Italy
Casa di Cura Poliambulanza
🇮🇹Brescia, BS, Italy
Ospedlae Generale Regionale
🇮🇹Bolzano, BZ, Italy
Presidio Ospedaliero Mariano Santo
🇮🇹Cosenza, CS, Italy
Nuovo Ospedale San Giovanni di Dio
🇮🇹Firenze, FI, Italy
Ospedale San Bartolomeo
🇮🇹Sarzana - Loc. Santa Caterina, SP, Italy
Azienda Ospedaliera - Univ. Ospedali Riuniti
🇮🇹Trieste, TS, Italy
Ospedale di Bentivoglio
🇮🇹Bentivoglio, BO, Italy
Ospedale Bellaria
🇮🇹Bologna, BO, Italy
Azienda Ospedaliera Sant'Anna e San Sebastiano
🇮🇹Caserta, CE, Italy
Azienda Ospedaliera Santa Croce e Carle
🇮🇹Cuneo, CN, Italy
Ospedlae Maggiore
🇮🇹Crema, CR, Italy
Ospedale Garibaldi - Nesima
🇮🇹Catania, CT, Italy
Ospedale di Venere
🇮🇹Bari - Carbonara, BA, Italy
Presidio Ospedaliero Moscati
🇮🇹Aversa, CE, Italy
Presidio Ospedaliero San Marco Argentano
🇮🇹San Marco Argentano, CS, Italy
Ospedale Civile "G. Chidichimo"
🇮🇹Trebisacce, CS, Italy
Ospedale Ignazio Veris Delli Ponti
🇮🇹Scorrano, LE, Italy
Ospedale Santa Maria degli Ungheresi
🇮🇹Polistena, RC, Italy
Casa di Cura Madonna della Salute
🇮🇹Porto Viro, RO, Italy
Ospedale G. Fucito
🇮🇹Mercato San Severino, SA, Italy
Ospedale Santa Corona
🇮🇹Pietra Ligure, SV, Italy
Santa Maria della Misericordia
🇮🇹Udine, UD, Italy
Ospedale Civile San Biagio
🇮🇹Bovolone, VR, Italy
Ospedale G. Fra Castoro
🇮🇹San Bonifacio, VR, Italy
Ospedale Valdichiana Santa Margherita
🇮🇹Cortona, AR, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, AT, Italy
Azienda Ospedaliera Giuseppe Moscati
🇮🇹Avellino, AV, Italy
Ospedale Consorziale Policlinico
🇮🇹Bari, BA, Italy
Ospedale Maggiore
🇮🇹Bologna, BO, Italy
Ospedale San Giuseppe e Melorio
🇮🇹Santa Maria Capua Vetere, CE, Italy
Ospedali Civili di Sampierdarena
🇮🇹Genova-Sampierdarena, GE, Italy
Ospedale Civile Campo di Marte
🇮🇹Lucca, LU, Italy
Ospedale San Filippo Neri
🇮🇹Roma, RM, Italy
Ospedale San Camillo
🇮🇹Roma, RM, Italy
Ospedale Infermi
🇮🇹Rimini, RN, Italy
Ospedale San Luca
🇮🇹Vallo della Lucania, SA, Italy
Casa di Cura Villa Bianca
🇮🇹Trento, TN, Italy
Ospedale Santa Chiara
🇮🇹Trento, TR, Italy
Azienda Ospedaliera e Universitaria
🇮🇹Varese, VA, Italy
Ospedale Generale di Zona
🇮🇹Giugliano in Campania, Italy
Cardiocentro Ticino
🇨ðŸ‡Lugano, Switzerland