Clincosm LogoSign in Get a demo

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

Sponsor
Gruppo di Ricerca GISSI (Other)
Overall Status
Completed
CT.gov ID
NCT00376272
Collaborator
(none)
1,442
Enrollment
114
Locations
2
Arms
40
Duration (Months)
12.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
1442 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Valsartan
Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. First recurrence of AF, [time to first AF recurrence]

  3. Rate of patients with more than one AF episode, [end of follow-up]

Secondary Outcome Measures

  1. Number of AF episodes [end of fw-up]

  2. Number of hospitalizations for CV reasons [end of fw-up]

  3. Number of all-cause hospitalizations [end of fw-up]

  4. Incidence of thromboembolic events [end of fw-up]

  5. Number of patients who die or with non-fatal thromboembolic events [end of fw-up]

  6. Number of patients in sinus rhythm at the time of each study visit [end of fw-up]

  7. Number of patients in sinus rhythm who did not have any prior AF recurrence during the study [end of fw-up]

  8. Duration and characteristics (ventricular rate) of the first recurrence of AF. [end of fw-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Valdichiana Santa Margherita Cortona AR Italy 52040
2 Ospedale Cardinal Massaia Asti AT Italy 14100
3 Azienda Ospedaliera Giuseppe Moscati Avellino AV Italy 83100
4 Ospedale di Venere Bari - Carbonara BA Italy 70012
5 Ospedale Consorziale Policlinico Bari BA Italy 70124
6 Ospedali Riuniti di Bergamo Bergamo BG Italy 24128
7 Ospedale di Bentivoglio Bentivoglio BO Italy 40010
8 Ospedale Maggiore Bologna BO Italy 40133
9 Ospedale Bellaria Bologna BO Italy 40139
10 Casa di Cura Poliambulanza Brescia BS Italy 25122
11 Ospedale Civile Mellini Chiari BS Italy 25032
12 Ospedlae Generale Regionale Bolzano BZ Italy 39100
13 Azienda Ospedaliera G. Brotzu - S. Michele Cagliari CA Italy 09134
14 Presidio Ospedaliero Moscati Aversa CE Italy 81031
15 Azienda Ospedaliera Sant'Anna e San Sebastiano Caserta CE Italy 81100
16 Ospedale Civile Ave Gratia Plena Piedimonte Matese CE Italy 81016
17 Ospedale Ave Gratia Plena San Felice a Cancello CE Italy 81027
18 Ospedale San Giuseppe e Melorio Santa Maria Capua Vetere CE Italy 81055
19 Azienda Ospedaliera Santa Croce e Carle Cuneo CN Italy 12100
20 Ospedale Civile Saluzzo Saluzzo CN Italy 12037
21 Ospedlae Maggiore Crema CR Italy 26013
22 Istituti Ospitalieri di Cremona Cremona CR Italy 26100
23 Ospedale Santissima Annunziata Cosenza CS Italy 87100
24 Presidio Ospedaliero Mariano Santo Cosenza CS Italy 87100
25 Ospedale San Francesco di Paola Paola CS Italy 87027
26 Ospedale Santa Barbara Rogliano CS Italy 87054
27 Presidio Ospedaliero San Marco Argentano San Marco Argentano CS Italy 87018
28 Ospedale Civile "G. Chidichimo" Trebisacce CS Italy 87075
29 Ospedale Garibaldi - Nesima Catania CT Italy 95122
30 Ospedale Civile Pugliese Catanzaro CZ Italy 88100
31 Ospedale Civile Lamezia Terme CZ Italy 88046
32 Azienda Ospedaliera Mater Domini Località Germaneto - Catanzaro CZ Italy 88100
33 Ospedale G. Basilotta Nicosia EN Italy 94014
34 Arcispedale Sant'Anna Ferrara FE Italy 44100
35 Ospedale Santa Maria Annunziata Bagno a Ripoli FI Italy 50011
36 Nuovo Ospedale San Giovanni di Dio Firenze FI Italy 50143
37 Ospedali Civili di Sampierdarena Genova-Sampierdarena GE Italy 16149
38 Ospedale San Carlo Genova-Voltri GE Italy 16158
39 Ospedale Civile San Paolo Monfalcone GO Italy 34072
40 Ospedale Civile Imperia IM Italy 18100
41 Ospedale Civile San Giovanni di Dio Crotone KR Italy 88900
42 Presidio Ospedaliero F. Ferrari Casarano LE Italy 73042
43 Ospedale Ignazio Veris Delli Ponti Scorrano LE Italy 73020
44 Ospedale Civile Bassa Val di Cecina Cecina LI Italy 57023
45 Ospedali Riuniti Livorno LI Italy 57124
46 Ospedale del dono Svizzero Formia LT Italy 04023
47 Ospedale Civile Campo di Marte Lucca LU Italy 55100
48 Ospedale Civile Milazzo ME Italy 98057
49 Ospedale Carlo Borella Giussano MI Italy 20034
50 Ospedale San Raffaele Milano MI Italy 20132
51 Istituto Clinico Humanitas Rozzano MI Italy 20089
52 Multimedica SPA Sesto San Giovanni MI Italy 20099
53 Ospedale Policlinico Modena MO Italy 41100
54 Nuovo Ospedale Civile di Sassuolo Sassuolo MO Italy 41049
55 Ospedale Madonna delle Grazie Matera MT Italy 75100
56 Ospedale Civile Policoro MT Italy 75025
57 Ospedale Buccheri La Ferla Fatebenefratelli Palermo PA Italy 90123
58 A.R.N.A.S. Ospedale Civico e Benfratelli Palermo PA Italy 90127
59 Ospedale V. Cervello Palermo PA Italy 90146
60 Presidio Ospedaliero Villa Sofia Palermo PA Italy 90146
61 Ospedale Generale Provinciale Este PD Italy 35042
62 Ospedale Civile San Massimo Penne PE Italy 65017
63 Ospedale Alta Valle del Tevere Città di Castello PG Italy 06012
64 Nuovo Ospedale San Giovanni Battista Foligno PG Italy 06034
65 Azienda Ospedaliera S. Maria degli Angeli Pordenone PN Italy 33170
66 Ospedale Civile Fidenza PR Italy 43036
67 Azienda Ospedaliera San Salvatore Pesaro PU Italy 61100
68 IRCCS - Fondazione Salvatore Maugeri Pavia PV Italy 27100
69 Ospedale Policlinico San Matteo IRCCS Pavia PV Italy 27100
70 Csa di Cura Villa Maria Cecilia Cotignola RA Italy 48010
71 Ospedale Santa Maria degli Ungheresi Polistena RC Italy 89024
72 Policlinico Madonna della Consolazione Reggio Calabria RC Italy 89124
73 Ospedale Scillesi D'America Scilla RC Italy 89024
74 Ospedali Riuniti Albano-Genzano Albano Laziale RM Italy 00041
75 Ospedale San Filippo Neri Roma RM Italy 00135
76 CTO Roma RM Italy 00145
77 Ospedale San Giovanni Roma RM Italy 00148
78 Ospedale San Camillo Roma RM Italy 00149
79 Ospedale San Camillo Roma RM Italy 00152
80 Ospedale Sant'Andrea Roma RM Italy 00189
81 Ospedale Infermi Rimini RN Italy 47900
82 Casa di Cura Madonna della Salute Porto Viro RO Italy 45014
83 Presidio Ospedaliero Rovigo RO Italy 45100
84 Ospedale G. Fucito Mercato San Severino SA Italy 84085
85 Ospedale San Luca Vallo della Lucania SA Italy 84078
86 Ospedale San Bartolomeo Sarzana - Loc. Santa Caterina SP Italy 19038
87 Ospedale Santa Corona Pietra Ligure SV Italy 17027
88 Casa di Cura Villa Verde Taranto TA Italy 74100
89 Ospedale SS. Annunziata Taranto TA Italy 74100
90 Ospedale Civile G. Mazzini Teramo TE Italy 64100
91 Ospedale di Cles Cles TN Italy 38023
92 Casa di Cura Villa Bianca Trento TN Italy 38100
93 Ospedale Evangelico Valdese Torino TO Italy 10125
94 Azienda USL 4 Terni Terni TR Italy 05100
95 Ospedale Santa Chiara Trento TR Italy 38100
96 Azienda Servizi Sanitari N. 1 Triestina Trieste TS Italy 34142
97 Azienda Ospedaliera - Univ. Ospedali Riuniti Trieste TS Italy 34149
98 Ospedale De Gironcoli Conegliano Veneto TV Italy 31015
99 Ospedale Santa Maria dei Battuti Conegliano Veneto TV Italy 31015
100 Ospedale di Ialmicco - Palmanova - Udine Palmanova UD Italy 33057
101 Ospedale S. Antonio San Daniele del Friuli UD Italy 33038
102 Santa Maria della Misericordia Udine UD Italy 33100
103 Azienda Ospedaliera e Universitaria Varese VA Italy 21100
104 Ospedale Civile Umberto I Mestre VE Italy 30171
105 Ospedale Civile Mirano VE Italy 30035
106 Ospedale Civile San Biagio Bovolone VR Italy 37051
107 Ospedale G. Fra Castoro San Bonifacio VR Italy 37047
108 Presidio Ospedaliero Soriano Calabro VV Italy 89831
109 Ospedale Civile G. Jazzolino Vibo Valentia VV Italy 89900
110 Ospedale Generale di Zona Giugliano in Campania Italy 80014
111 Azienda Ospedaliera Vincenzo Monaldi Napoli Italy 80131
112 Policlinico Universitario Federico II Napoli Italy 80131
113 Ospedale Santa Maria delle Grazie Pozzuoli Italy 80078
114 Cardiocentro Ticino Lugano Switzerland 6900

Sponsors and Collaborators

  • Gruppo di Ricerca GISSI

Investigators

  • Study Chair: Marcello Disertori, MD, Gruppo di Ricerca GISSI
  • Study Chair: Roberto Latini, MD, Gruppo di Ricerca GISSI

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00376272
Other Study ID Numbers:
  • G106
First Posted:
Sep 14, 2006
Last Update Posted:
Apr 20, 2009
Last Verified:
Apr 1, 2009
Keywords provided by , ,
atrial fibrillation,atrial remodeling,dysrhythmias,valsartan
Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Valsartan

Study Results

No Results Posted as of Apr 20, 2009