Heart Failure Clinical Trial
— BRING-UP3HFOfficial title:
BRING-UP 3 Heart Failure
NCT number | NCT06279988 |
Other study ID # | K24 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2023 |
Est. completion date | July 30, 2026 |
The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | July 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years old. 2. Males and females at birth. 3. Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment). 4. Ambulatory chronic HF or Hospitalized de-novo or worsening HF. 5. Signed informed consent Diagnosis will be made by the local attending physician following the ESC guidelines recommendations. Exclusion Criteria: 1. Active neoplasia or very severe disease compromising short-medium term life expectancy. 2. Participation in interventional studies. 3. Patients already enrolled into the study from another participating center or in the previous enrolling phase. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Miulli - U.O.C. Cardiologia - Utic | Acquaviva Delle Fonti | BA |
Italy | Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic | Altamura | BA |
Italy | Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia | Ancona | AN |
Italy | Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic | Ancona | AN |
Italy | Ospedale San Donato - U.O.C Cardiologia | Arezzo | AR |
Italy | Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic | Ariccia | RM |
Italy | Ospedale Civile - U.O.C. Di Cardiologia | Arzignano | VI |
Italy | Ospedale E. Muscatello - U.O. Di Cardiologia - Utic | Augusta | SR |
Italy | Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' | Avellino | AV |
Italy | Ospedale G. Di Maria - Cardiologia Utic | Avola | SR |
Italy | Ics Maugeri Spa Societa' Benefit Irccs Bari - Cardiologia Riabilitativa | Bari | BA |
Italy | Mater Dei Hospital - Riabilitazione Cardiologica | Bari | BA |
Italy | Ospedale San Paolo - Cardiologia-Utic | Bari | BA |
Italy | Ospedale Monsignor Angelo R. Di Miccoli - Uoc Cardiologia/Utic | Barletta | BT |
Italy | Ospedale Di Bentivoglio - U.O. Cardiologia Pianura | Bentivoglio | BO |
Italy | Asst Papa Giovanni Xxiii - Sc Cardiologia 1 | Bergamo | MI |
Italy | Ospedale Maggiore - U.O.C. Di Cardiologia | Bologna | BO |
Italy | Ospedale Policlinico S. Orsola-Malpighi - Medicina Interna - Borghi | Bologna | BO |
Italy | Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali | Bolzano | BZ |
Italy | Ospedale Ss. Trinita' - S.C. Di Cardiologia | Borgomanero | |
Italy | Istituto Ospedaliero Fondazione Poliambulanza - Unita Operativa Di Cardiologia E Utic | Brescia | BS |
Italy | Ospedale Perrino - U.O.C. Di Cardiologia | Brindisi | BR |
Italy | Nuovo Ospedale Versilia - Sc Cardiologia | Camaiore | LU |
Italy | Ospedale Caduti in Guerra - U.O.S.V.D Di Riabilitazione Cardiologica | Canosa Di Puglia | BT |
Italy | Ospedale Di Venere - U.O.C. Di Cardiologia | Carbonara Di Bari | BA |
Italy | Ospedale Santo Spirito - Sc Cardiologia | Casale Monferrato | AL |
Italy | Ospedale Oglio Po - U.O. Di Cardiologia-Utic | Casalmaggiore | CR |
Italy | Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic | Caserta | CE |
Italy | Villa Delle Magnolie - Riabilitazione Cardiologica | Castel Morrone | CE |
Italy | Ospedale Unico Della Val Tidone - Cardiologia E Riabilitazione | Castel San Giovanni | PC |
Italy | Ospedale Multimedica Castellanza - Cardiologia | Castellanza | VA |
Italy | Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist. | Castelnuovo Di Garfagnana | LU |
Italy | Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic | Castrovillari | CS |
Italy | Azienda Ospedaliera Cannizzaro - Uoc Cardiologia | Catania | CT |
Italy | P.O. Garibaldi-Nesima - Arnas Garibaldi - U.O.C. Di Cardiologia Con Utic | Catania | CT |
Italy | Policlinico Catania Po G. Rodolico - Cardiologia Utic | Catania | CT |
Italy | P.O. "Materdomini" - A.O.U. "Renato Dulbecco" - Ssd Cardiologia Riabilitativa | Catanzaro | CZ |
Italy | P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica | Catanzaro | CZ |
Italy | Fondazione G. Giglio - U.O. Di Cardiologia | Cefalu' | PA |
Italy | Ospedale Ss. Annunziata - U.O. Di Cardiologia Provinciale | Cento | FE |
Italy | Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc | Cernusco Sul Naviglio | MI |
Italy | Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic | Chieti | CH |
Italy | Ospedale Civico - Sc Cardiologia | Chivasso | TO |
Italy | Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg) | Cinisello Balsamo | MI |
Italy | Por Cirié- Lanzo Presidio Cirié - S.C. Cardiologia | Cirié | TO |
Italy | Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic | Citta' Di Castello | PG |
Italy | Ospedale Civita Castellana - Ssd Cardiologia | Civita Castellana | VT |
Italy | Ospedale Civile San Paolo - U.O.C. Cardiologia - Utic | Civitavecchia | RM |
Italy | Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia | Copertino | LE |
Italy | Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona | Cortona | AR |
Italy | Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia | Cuneo | CN |
Italy | Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C. | Desenzano Del Garda | BS |
Italy | Ospedale Pio Xi - U.O.C. Di Cardiologia | Desio | MB |
Italy | Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic | Eboli | SA |
Italy | Ospedale San Giuseppe - Cardiologia | Empoli | FI |
Italy | Presidio Ospedaliero Umberto I - Cardiologia - Utic- Riabilitazione | Enna | EN |
Italy | Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic | Feltre | BL |
Italy | Arcispedale Sant'Anna - U.O. Cardiologia | Ferrara | FE |
Italy | Ospedale Civile - U.O.C. Cardiologia - Utic | Fidenza | PR |
Italy | Aou Careggi - Geriatria - Utig | Firenze | FI |
Italy | Ospedale San Giovanni Di Dio - Sos Cardiologia | Firenze | FI |
Italy | Ospedale Santa Maria Nuova - Cardiologia | Firenze | FI |
Italy | Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic | Foggia | FG |
Italy | Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia | Foligno | PG |
Italy | Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia | Forli' | FC |
Italy | Istituti Clinici Scientifici Maugeri Irccs Sede Di Veruno - Uo Cardiologia Riabilitativa | Gattico | |
Italy | Ospedale Civile 'La Memoria' - U.O. Di Cardiologia | Gavardo | BS |
Italy | Irccs Ospedale Policlinico San Martino - Clinica Malattie Apparato Cardiovascolare | Genova | GE |
Italy | Ospedale Padre Antero Micone - Sc Cardiologia - Utic | Genova | GE |
Italy | Ospedale San Giovanni Di Dio - Sc Cardiologia (Gorizia-Monfalcone) | Gorizia | GO |
Italy | Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord | Guastalla | RE |
Italy | Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia | Gubbio | PG |
Italy | Ospedale Civile - S.C. Cardiologia | Ivrea | TO |
Italy | Ospedale Anna Rizzoli - Cardiologia-Utic | Lacco Ameno | |
Italy | Ospedale Del Delta - U.O. Cardiologia | Lagosanto | FE |
Italy | Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic | Lavagna | GE |
Italy | Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica | Lecce | LE |
Italy | Ospedale Alessandro Manzoni - S.C. Di Cardiologia | Lecco | LC |
Italy | Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica | Legnano | MI |
Italy | Ospedali Riuniti - U.O.C. Cardiologia E Utic | Livorno | LI |
Italy | Ospedale Civile - Uo Servizio Cardiologia | Lugo | RA |
Italy | Istituti Clinici Scientifici Maugeri Irccs Sede Di Lumezzane - U.O. Di Cardiologia Riabilitativa | Lumezzane | BS |
Italy | Ospedale Generale Provinciale - U.O. Cardiologia | Macerata | MC |
Italy | Casa Di Cura San Michele - Uo Cardiologia | Maddaloni | CE |
Italy | Ospedale S. Andrea - Alta Maremma - Uosd Cardiologia | Massa Marittima | GR |
Italy | Ospedale Madonna Delle Grazie - Ssd Utic | Matera | Mount |
Italy | Azienda Ospedaliera Papardo - U.O. Cardiologia Con Utic - Emodinamica | Messina | ME |
Italy | Irccs Centro Neurolesi Bonino Pulejo - P.O Piemonte - Cardiologia E Utic | Messina | ME |
Italy | Ospedale Dell'Angelo - U.O.C. Cardiologia | Mestre | VE |
Italy | Asst Ospedale Metropolitano Niguarda - Cardiologia 2 - Insufficienza Cardiaca E Trapianto | Milano | MI |
Italy | ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC | Milano | MI |
Italy | Centro Cardiologico Monzino Irccs - Scompenso,Cardiologia Clinica | Milano | MI |
Italy | Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari | Milano | MI |
Italy | Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco | Milano | MI |
Italy | Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Riabilitazione Cardiologica | Milano | MI |
Italy | Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Uo Cure Subacute | Milano | MI |
Italy | Ospedale Fatebenefratelli E Oftalmico - Cardiologia E U.C.C. | Milano | MI |
Italy | Ospedale Santa Maria Bianca - U.O. Di Cardiologia | Mirandola | MO |
Italy | Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic | Mondovì | CN |
Italy | Ospedale Civile San Polo - Sc Cardiologia (Gorizia-Monfalcone) | Monfalcone | GO |
Italy | Ospedale San Giacomo - Uoc Cardiologia | Monopoli | BA |
Italy | Ospedali Riuniti Padova Sud - U.O.C. Cardiologia | Monselice | PD |
Italy | Policlinico Di Monza - Cardiologia Clinica E Utic | Monza | MB |
Italy | Aorn Cardarelli - U.O. Cardiologia Con Utic | Napoli | |
Italy | Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Card. Riabilitativa Intensiva E Scompenso | Napoli | |
Italy | Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Malattie Cardiologiche Congenite Adulti-Guch | Napoli | |
Italy | Ospedale Buon Consiglio Fatebenefratelli - U.O.Complessa Di Cardiologia E Utic | Napoli | |
Italy | Ospedale S. Giovanni Bosco - Sc Cardiologia - Utic | Napoli | |
Italy | Ospedale P.F. Calvi - Uos Di Cardiologia Riabilitativa | Noale | VE |
Italy | Aou Maggiore Della Carita' - Scdo Cardiologia Ii | Novara | |
Italy | Ospedale San Giacomo - Sc Cardiologia | Novi Ligure | AL |
Italy | Ospedale Giovanni Paolo Ii - Utic - Cardiologia | Olbia | OT |
Italy | Aou San Luigi Gonzaga - S.C.D.O. Cardiologia | Orbassano | TO |
Italy | Clinica San Carlo - U.O. Cardiologia-Unita'Cure Coronariche | Paderno Dugnano | MI |
Italy | Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello | Palermo | PA |
Italy | Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia | Palermo | PA |
Italy | Arnas P.O. Civico E Benfratelli - Uoc Utic | Palermo | PA |
Italy | Arnas P.O. Civico E Benfratelli - Uosd Cardiologia Clinica Trattam. Scompenso Card. | Palermo | PA |
Italy | Maria Eleonora Hospital - Cardiologia | Palermo | PA |
Italy | Ospedale Buccheri La Ferla Fatebenefratelli - Ssd Riabilitazione Cardiovascolare | Palermo | PA |
Italy | Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia | Paola | CS |
Italy | Presidio Ospedaliero Di Passirana - Cardiologia Riabilitativa | Passirana | MI |
Italy | Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1 | Pavia | PV |
Italy | Istituti Clinici Scientifici Maugeri Irccs Sede Di Pavia - U.O. Di Riabilitazione Cardiologica | Pavia | PV |
Italy | Centro Servizi Grocco - Cardiologia Riabilitativa E Prevenzione | Perugia | PG |
Italy | Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic | Pescara | PE |
Italy | Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic | Piacenza | PC |
Italy | Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente | Pietra Ligure | SV |
Italy | Ospedale Villamarina - Cardiologia E Utic Piombino Elba | Piombino | LI |
Italy | Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare | Pisa | PI |
Italy | Ospedale San Jacopo - Soc Cardiologia | Pistoia | Point |
Italy | Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic | Poggibonsi | SI |
Italy | Ospedale Giovanni Paolo Ii - Uosd Utic | Policoro | Mount |
Italy | Ospedale Degli Infermi - Sc Di Cardiologia | Ponderano | BI |
Italy | Ospedale Generale Provinciale Lotti - U.O. Malattie Cardiovascolari Vde E Avc | Pontedera | PI |
Italy | Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica | Pozzuoli | |
Italy | Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia | Ravenna | RA |
Italy | Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera | Reggio Emilia | RE |
Italy | P.O. San Camillo de Lellis - U.O.C. Cardiologia | Rieti | RI |
Italy | Ospedale Infermi - U.O. Cardiologia | Rimini | RN |
Italy | Ao San Giovanni Addolorata - Uoc Cardiologia D'Urgenza E Utic | Roma | RM |
Italy | Campus Biomedico - Cardiologia | Roma | RM |
Italy | Inmi Lazzaro Spallanzani Irccs - Servizio Di Cardiologia Del Dipartimento Clinico | Roma | RM |
Italy | Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic | Roma | RM |
Italy | Ospedale San Camillo - Uoc Cardiologia | Roma | RM |
Italy | Ospedale Sandro Pertini - Uoc Cardiologia | Roma | RM |
Italy | Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia | Roma | RM |
Italy | Ospedale Santo Spirito - Uoc Cardiologia | Roma | RM |
Italy | P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa | Roma | RM |
Italy | Policlinico Casilino - U.O.C. Cardiologia | Roma | RM |
Italy | Ospedale Santa Maria Del Carmine - Cardiologia | Rovereto | Trento |
Italy | Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc | Rozzano | MI |
Italy | Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva Ospedaliera | Salerno | SA |
Italy | Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic | Salerno | SA |
Italy | Ospedale G. Fracastoro - U.O.C. Di Cardiologia | San Bonifacio | VR |
Italy | Irccs Policlinico San Donato - U.O. Cardiologia Con Utic | San Donato Milanese | MI |
Italy | Ospedale S. Anna - U.O.C. Di Cardiologia | San Fermo Della Battaglia | CO |
Italy | Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic | San Gavino Monreale | SU |
Italy | Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica | San Giovanni Rotondo | FG |
Italy | Ospedale Di S. Vito Al Tagliamento - Ssd Cardiologia San Vito - Spilimbergo | San Vito Al Tagliamento | PN |
Italy | Ospedale Alto Vicentino - U.O.C. Cardiologia - Ucic | Santorso | VI |
Italy | Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia | Saronno | VA |
Italy | Ospedale San Bartolomeo - Sc Riabilitazione Cardiologica | Sarzana | SP |
Italy | Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica | Sassari | SS |
Italy | Ospedale Di Sassuolo - Cardiologia | Sassuolo | MO |
Italy | Ospedale Maggiore Ss. Annunziata - Sc Cardiologia | Savigliano | CN |
Italy | P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante | Savona | SV |
Italy | Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei" | Scorrano | LE |
Italy | Irccs Policlinico Multimedica - Uo Di Cardiologia | Sesto San Giovanni | MI |
Italy | Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia | Siena | SI |
Italy | Casa Di Cura Villa Verde - Cardiologia | Taranto | TA |
Italy | Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic | Tivoli | RM |
Italy | Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U | Torino | TO |
Italy | Ospedale Maria Vittoria - Cardiologia (Mrt-Mv) | Torino | To |
Italy | Ospedale Martini - Cardiologia (Mrt-Mv) | Torino | TO |
Italy | Ospedale San Giovanni Bosco - Sc Cardiologia | Torino | TO |
Italy | Ospedale Di Circolo Galmarini - Cardiologia | Tradate | VA |
Italy | Ospedale Santa Chiara - Divisione Di Cardiologia | Trento | TN |
Italy | Asugi Trieste - Sc Patologie Cardiovascolari | Trieste | TS |
Italy | Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia | Udine | UD |
Italy | Ospedale San Luca - U.O. Utic - Cardiologia | Vallo Della Lucania | SA |
Italy | Ospedale Sant'Andrea - Sc Cardiologia | Vercelli | VC |
Italy | Ospedale Pietro E Michele Ferrero - Cardiologia E Utic | Verduno | CN |
Italy | Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic | Vimercate | MB |
Italy | Ospedale Belcolle - Uoc Cardiologia Ed Emodinamica | Viterbo | VT |
Italy | Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic | Vittoria | RG |
Italy | Ospedale Civile - U.O. Di Cardiologia | Voghera | PV |
Lead Sponsor | Collaborator |
---|---|
Heart Care Foundation |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF | To assess the rate of patients with HFrEF appropriately treated with the 4 therapeutic pillars [Angiotensin Converting Enzyme Inhibitors (ACE-i)/Angiotensin Receptor Blockers (ARBs)/Angiotensin Receptor/Neprilysin Inhibitor (ARNI), betablockers, mineralocorticoid receptor antagonist (MRAs), Sodium-Glucose Co-Transporter-2 (SGLT2i)] recommended by current European Society of Cardiology (ESC) 2021 guidelines. Patients with a documented contraindication to one or more of the 4 recommended therapeutic pillars will be included in the group of appropriately treated patients. | 6 months | |
Secondary | Rate of patient achieving appropriate dosages of GDMTs | to assess the rate of patients treated with appropriate dosages* of:ACE-i/ARBs/ARNI, betablockers, MRAs, SGLT2i and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice
*For the purpose of the present study appropriate dosage is defined as a dosage =50% of the maximal recommended dosage by the current guidelines |
6 months | |
Secondary | Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF) | To assess how novel treatment recommendations for HFmrEF and HFpEF are implemented in practice, specifically the rate of use of ARNI and SGLT2i and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice | 6 months | |
Secondary | Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF | To assess the rate of use of vasopressors, vasodilators, renal replacement therapy and mechanical circulatory support, pharmacological treatments and follow-up planning at discharge and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice. | 6 months | |
Secondary | All cause and specific causes of death and hospitalization (Exploratory endpoint) | To evaluate the rate of occurrence of clinical events during the 12 months follow-up of each enrolment phase. Specifically all-cause death, all-cause hospitalizations, specific causes of death and hospitalizations. | 12 months |
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