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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2024
Source Heart Care Foundation
Contact Fabrizio G Oliva, MD
Phone 055/5101361
Email bringup3.scompenso@heartcarefoundation.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers. Phases 1: 1. First educational intervention to discuss the recommendations of guidelines and treatment patterns in specific phenotypes of patients. 2. Data collection for 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening). 3. Evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up. 4. Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice. 5. New data collection for other 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening). 6. Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up. 7. 12-month follow-up for all patients included in both enrolment phases of the study.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Heart Care Foundation

Country where clinical trial is conducted

Italy, 

Outcome

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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