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Atrial FibrillationPhase 3NCT00376272

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

A Phase 3 study testing Valsartan in people with Atrial Fibrillation, run by Gruppo di Ricerca GISSI at 114 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Valsartan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,442 participants
Where
114 sitesin 2 countries
Study dates
Nov 2004to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

114 sites in 2 countries.

114 sites in 2 countries

Italy113 sites

  • Ospedali Riuniti Albano-Genzano

    Albano Laziale, RM, 00041

  • Ospedale Cardinal Massaia

    Asti, AT, 14100

  • Azienda Ospedaliera Giuseppe Moscati

    Avellino, AV, 83100

  • Presidio Ospedaliero Moscati

    Aversa, CE, 81031

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli, FI, 50011

  • Ospedale Consorziale Policlinico

    Bari, BA, 70124

  • Ospedale di Venere

    Bari - Carbonara, BA, 70012

  • Ospedale di Bentivoglio

    Bentivoglio, BO, 40010

  • Ospedali Riuniti di Bergamo

    Bergamo, BG, 24128

  • Ospedale Maggiore

    Bologna, BO, 40133

  • Ospedale Bellaria

    Bologna, BO, 40139

  • Ospedlae Generale Regionale

    Bolzano, BZ, 39100

  • Ospedale Civile San Biagio

    Bovolone, VR, 37051

  • Casa di Cura Poliambulanza

    Brescia, BS, 25122

  • Azienda Ospedaliera G. Brotzu - S. Michele

    Cagliari, CA, 09134

  • Presidio Ospedaliero F. Ferrari

    Casarano, LE, 73042

  • Azienda Ospedaliera Sant'Anna e San Sebastiano

    Caserta, CE, 81100

  • Ospedale Garibaldi - Nesima

    Catania, CT, 95122

  • Ospedale Civile Pugliese

    Catanzaro, CZ, 88100

  • Ospedale Civile Bassa Val di Cecina

    Cecina, LI, 57023

  • Ospedale Civile Mellini

    Chiari, BS, 25032

  • Ospedale Alta Valle del Tevere

    Città di Castello, PG, 06012

  • Ospedale di Cles

    Cles, TN, 38023

  • Ospedale De Gironcoli

    Conegliano Veneto, TV, 31015

  • Ospedale Santa Maria dei Battuti

    Conegliano Veneto, TV, 31015

  • Ospedale Valdichiana Santa Margherita

    Cortona, AR, 52040

  • Ospedale Santissima Annunziata

    Cosenza, CS, 87100

  • Presidio Ospedaliero Mariano Santo

    Cosenza, CS, 87100

  • Csa di Cura Villa Maria Cecilia

    Cotignola, RA, 48010

  • Ospedlae Maggiore

    Crema, CR, 26013

  • Istituti Ospitalieri di Cremona

    Cremona, CR, 26100

  • Ospedale Civile San Giovanni di Dio

    Crotone, KR, 88900

  • Azienda Ospedaliera Santa Croce e Carle

    Cuneo, CN, 12100

  • Ospedale Generale Provinciale

    Este, PD, 35042

  • Arcispedale Sant'Anna

    Ferrara, FE, 44100

  • Ospedale Civile

    Fidenza, PR, 43036

  • Nuovo Ospedale San Giovanni di Dio

    Florence, FI, 50143

  • Nuovo Ospedale San Giovanni Battista

    Foligno, PG, 06034

  • Ospedale del dono Svizzero

    Formia, LT, 04023

  • Ospedali Civili di Sampierdarena

    Genova-Sampierdarena, GE, 16149

  • Ospedale San Carlo

    Genova-Voltri, GE, 16158

  • Ospedale Generale di Zona

    Giugliano in Campania, 80014

  • Ospedale Carlo Borella

    Giussano, MI, 20034

  • Ospedale Civile

    Imperia, IM, 18100

  • Ospedale Civile

    Lamezia Terme, CZ, 88046

  • Ospedali Riuniti

    Livorno, LI, 57124

  • Azienda Ospedaliera Mater Domini

    Località Germaneto - Catanzaro, CZ, 88100

  • Ospedale Civile Campo di Marte

    Lucca, LU, 55100

  • Ospedale Madonna delle Grazie

    Matera, MT, 75100

  • Ospedale G. Fucito

    Mercato San Severino, SA, 84085

  • Ospedale Civile Umberto I

    Mestre, VE, 30171

  • Ospedale San Raffaele

    Milan, MI, 20132

  • Ospedale Civile

    Milazzo, ME, 98057

  • Ospedale Civile

    Mirano, VE, 30035

  • Ospedale Policlinico

    Modena, MO, 41100

  • Ospedale Civile San Paolo

    Monfalcone, GO, 34072

  • Azienda Ospedaliera Vincenzo Monaldi

    Naples, 80131

  • Policlinico Universitario Federico II

    Naples, 80131

  • Ospedale G. Basilotta

    Nicosia, EN, 94014

  • Ospedale Buccheri La Ferla Fatebenefratelli

    Palermo, PA, 90123

  • A.R.N.A.S. Ospedale Civico e Benfratelli

    Palermo, PA, 90127

  • Ospedale V. Cervello

    Palermo, PA, 90146

  • Presidio Ospedaliero Villa Sofia

    Palermo, PA, 90146

  • Ospedale di Ialmicco - Palmanova - Udine

    Palmanova, UD, 33057

  • Ospedale San Francesco di Paola

    Paola, CS, 87027

  • IRCCS - Fondazione Salvatore Maugeri

    Pavia, PV, 27100

  • Ospedale Policlinico San Matteo IRCCS

    Pavia, PV, 27100

  • Ospedale Civile San Massimo

    Penne, PE, 65017

  • Azienda Ospedaliera San Salvatore

    Pesaro, PU, 61100

  • Ospedale Civile Ave Gratia Plena

    Piedimonte Matese, CE, 81016

  • Ospedale Santa Corona

    Pietra Ligure, SV, 17027

  • Ospedale Civile

    Policoro, MT, 75025

  • Ospedale Santa Maria degli Ungheresi

    Polistena, RC, 89024

  • Azienda Ospedaliera S. Maria degli Angeli

    Pordenone, PN, 33170

  • Casa di Cura Madonna della Salute

    Porto Viro, RO, 45014

  • Ospedale Santa Maria delle Grazie

    Pozzuoli, 80078

  • Policlinico Madonna della Consolazione

    Reggio Calabria, RC, 89124

  • Ospedale Infermi

    Rimini, RN, 47900

  • Ospedale Santa Barbara

    Rogliano, CS, 87054

  • Ospedale San Filippo Neri

    Roma, RM, 00135

  • CTO

    Roma, RM, 00145

  • Ospedale San Giovanni

    Roma, RM, 00148

  • Ospedale San Camillo

    Roma, RM, 00149

  • Ospedale San Camillo

    Roma, RM, 00152

  • Ospedale Sant'Andrea

    Roma, RM, 00189

  • Presidio Ospedaliero

    Rovigo, RO, 45100

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • Ospedale Civile Saluzzo

    Saluzzo, CN, 12037

  • Ospedale G. Fra Castoro

    San Bonifacio, VR, 37047

  • Ospedale S. Antonio

    San Daniele del Friuli, UD, 33038

  • Ospedale Ave Gratia Plena

    San Felice A Cancello, CE, 81027

  • Presidio Ospedaliero San Marco Argentano

    San Marco Argentano, CS, 87018

  • Ospedale San Giuseppe e Melorio

    Santa Maria Capua Vetere, CE, 81055

  • Ospedale San Bartolomeo

    Sarzana - Loc. Santa Caterina, SP, 19038

  • Nuovo Ospedale Civile di Sassuolo

    Sassuolo, MO, 41049

  • Ospedale Scillesi D'America

    Scilla, RC, 89024

  • Ospedale Ignazio Veris Delli Ponti

    Scorrano, LE, 73020

  • Multimedica SPA

    Sesto San Giovanni, MI, 20099

  • Presidio Ospedaliero

    Soriano Calabro, VV, 89831

  • Casa di Cura Villa Verde

    Taranto, TA, 74100

  • Ospedale SS. Annunziata

    Taranto, TA, 74100

  • Ospedale Civile G. Mazzini

    Teramo, TE, 64100

  • Azienda USL 4 Terni

    Terni, TR, 05100

  • Ospedale Evangelico Valdese

    Torino, TO, 10125

  • Ospedale Civile "G. Chidichimo"

    Trebisacce, CS, 87075

  • Casa di Cura Villa Bianca

    Trento, TN, 38100

  • Ospedale Santa Chiara

    Trento, TR, 38100

  • Azienda Servizi Sanitari N. 1 Triestina

    Trieste, TS, 34142

  • Azienda Ospedaliera - Univ. Ospedali Riuniti

    Trieste, TS, 34149

  • Santa Maria della Misericordia

    Udine, UD, 33100

  • Ospedale San Luca

    Vallo della Lucania, SA, 84078

  • Azienda Ospedaliera e Universitaria

    Varese, VA, 21100

  • Ospedale Civile G. Jazzolino

    Vibo Valentia, VV, 89900

Other trials in Italy

Switzerland1 site

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

About this study

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 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.

Read more

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
Read the detailed description

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

Being tested
Valsartan, Placebo
Keywords
atrial fibrillation,atrial remodeling,dysrhythmias,valsartan
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ValsartanDrug

  • PlaceboDrug

Study groups in NCT00376272
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Valsartan
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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:

    Measured: Time to first AF recurrence

  2. First recurrence of AF,

    Measured: time to first AF recurrence

  3. Rate of patients with more than one AF episode,

    Measured: end of follow-up

Secondary outcomes (8)

  1. Number of AF episodes

    Measured: end of fw-up

  2. Number of hospitalizations for CV reasons

    Measured: end of fw-up

  3. Number of all-cause hospitalizations

    Measured: end of fw-up

  4. Incidence of thromboembolic events

    Measured: end of fw-up

  5. Number of patients who die or with non-fatal thromboembolic events

    Measured: end of fw-up

  6. Number of patients in sinus rhythm at the time of each study visit

    Measured: end of fw-up

  7. Number of patients in sinus rhythm who did not have any prior AF recurrence during the study

    Measured: end of fw-up

  8. Duration and characteristics (ventricular rate) of the first recurrence of AF.

    Measured: end of fw-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionJan 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376272
Sponsor's protocol ID
G106
Status last verified
Apr 2009
First submitted
12 Sep 2006
Last updated
20 Apr 2009
Results posted
No
Data monitoring committee
Yes

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. doi: 10.2459/01.JCM.0000199778.85343.08.

    PubMed 16645357

  • 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.

    PubMed 19369667

  • 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.

    PubMed 23586654

  • 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.

    PubMed 21926261

  • 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.

    PubMed 21835301

  • 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.

    PubMed 20435196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valsartan in people with Atrial Fibrillation, run by Gruppo di Ricerca GISSI at 114 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376272, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2009.

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