BLITZ Heart Failure

Heart Failure Clinical Trial

— BLITZ-HF  

Official title:

BLITZ Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661060
• Other study ID #: K15
• Status: Completed
• Start date: March 8, 2017
• Est. completion date: July 2, 2019

Study information

• Verified date: August 2018
• Source: Heart Care Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate if Italian Cardiologists are treating Heart Failure (HF) patients according to International guidelines and if a structured educational program can improved their adherence.

Description:

Multicentre, cross-sectional, prospective, non-interventional, observational study designed to evaluate the level of adherence to current ESC guidelines recommendations in both acute and chronic HF patients enrolled in each participating center and to verify if a specific HF educational intervention composed by an educational web based program of data collection and face to face meetings is able to improve adherence to guidelines recommendations evaluated during a second enrollment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7569
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients with chronic HF and those admitted for acute (de novo) or worsening chronic HF.

• Chronic HF: any NYHA class (I-IV).

• Acute HF Only patients in NYHA class III or IV, or with pulmonary edema or cardiogenic shock for whom an IV therapy specific for HF (diuretic, vasodilators, vasopressors) is administered.

• Any gender.

• Any etiology of HF.

• Any level of EF.

• Written informed consent.

Exclusion Criteria:

• - Age <18 years.

• Inclusion in registries or trials that can influence, by protocol, the clinical management of patients.

• Patients already enrolled in the BLITZ HF (by another participating centre or in the first enrollment period).

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	Aslrm6-Polo H2 Albano-Genzano - U.O.C. Di Cardiologia E Utic	Albano Laziale	RM
Italy	Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic	Ancona	AN
Italy	Ospedali Riuniti Anzio-Nettuno - U.O. Di Cardiologia - Utic	Anzio	RM
Italy	Ospedale Generale Regionale-Po U. Parini - U.O. Cardiologia E Cure Intensive Card.	Aosta	AO
Italy	Ospedale Civile - U.O.C. Cardiologia	Arzignano	VI
Italy	Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia	Ascoli Piceno	AP
Italy	Ospedale Di Assisi - Unita' Integrata Scompenso Cardiaco	Assisi	PG
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	Ospedale Monsignor Angelo R. Di Miccoli - Unita' Operativa Di Cardiologia	Barletta	BT
Italy	Presidio Osped. S. Maria Della Speranza - U.O. Di Cardiologia	Battipaglia	SA
Italy	Asst Papa Giovanni Xxiii - Cardiologia 1	Bergamo	BG
Italy	Ospedale Vittorio Emanuele Ii - Cardiologia	Bisceglie	BT
Italy	Ospedale Bellaria - U.O. Di Cardiologia	Bologna	BO
Italy	Ospedale Maggiore - U.O. Di Cardiologia	Bologna	BO
Italy	Ospedale Policlinico S. Orsola-Malpighi - Medicina Interna - Borghi	Bologna	BO
Italy	Istituto Osped. Fondazione Poliambulanza - Unita' Operativa Di Cardiologia	Brescia	BS
Italy	Spedali Civili - Cardiologia	Brescia	BS
Italy	Ospedale Perrino - U.O.C. Di Cardiologia	Brindisi	BR
Italy	Ospedale Di Circolo Di Busto Arsizio - Uoc Cardiologia Utic Emodinamica	Busto Arsizio	VA
Italy	Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia	Cagliari	CA
Italy	Ospedale Ramazzini - U.O. Cardiologia	Carpi	MO
Italy	P.O. Garibaldi Centro - U.O.C. Cardiologia	Catania	CT
Italy	P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia	Catania	CT
Italy	Policlinico Catania Po G. Rodolico - Ssd Scompenso Cardiaco Grave	Catania	CT
Italy	Fondazione G. Giglio - U.O. Cardiologia E Utic	Cefalù	PA
Italy	Ospedale M.Bufalini - U.O. Di Cardiologia-Utic	Cesena	FC
Italy	Ospedale Civile - U.O.C. Cardiologia	Chioggia	VE
Italy	Por Cirie'- Lanzo Presidio Cirie' - S.C. Cardiologia Cirie'- Ivrea	Ciriè	TO
Italy	Presidio Ospedaliero Citta' Di Castello - U.O. Di Cardiologia	Città Di Castello	PG
Italy	Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic	Copertino	LE
Italy	Ospedale Civile San Sebastiano - Sos Cardiologia Area Nord	Correggio	RE
Italy	Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu	Cortona	AR
Italy	Ospedale Maggiore - U.O. Cardiologia E Utic	Crema	CR
Italy	Ospedale Di Cremona - Uo Di Cardiologia	Cremona	CR
Italy	Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic	Eboli	SA
Italy	Ospedale Civile San Giuseppe - Cardiologia	Empoli	FI
Italy	Ospedale Santa Maria Del Prato - U.O. Di Cardiologia	Feltre	BL
Italy	Ospedale Civile Augusto Murri - U.O. Cardiologia	Fermo	FM
Italy	Arcispedale Sant'Anna - U.O. Cardiologia - Utic	Ferrara	FE
Italy	Aou Careggi - Geriatria - Utig	Firenze	FI
Italy	Ospedale San Giovanni Di Dio - Cardiologia	Firenze	FI
Italy	Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic	Firenze	FI
Italy	Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic	Foggia	FG
Italy	Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia	Forlì	FC
Italy	Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic	Frattamaggiore
Italy	Ospedale S. Antonio Abate - U.O. Di Cardiologia	Gallarate	VA
Italy	Ospedale Civile 'La Memoria' - U.O. Di Cardiologia	Gavardo	BS
Italy	Ospedale Padre Antero Micone - Sc Cardiologia - Utic	Genova	GE
Italy	Ospedale Policlinico San Martino - Unita' Operativa Cardiologia	Genova	GE
Italy	Ospedale Villa Scassi - Sc Cardiologia Utic	Genova	GE
Italy	Ospedale Generale Di Zona - U.O. Cardiologia - Utic	Giugliano In Campania
Italy	Ospedale Civile - Sc Cardiologia Area Nord	Guastalla	RE
Italy	Ospedale Civile - S.C. Cardiologia Cirie' Ivrea	Ivrea	TO
Italy	Ospedale Giovanni Paolo Ii - U.O. Cardiologia E Utic	Lamezia Terme	CZ
Italy	Ospedale Civile - Uo Cardiologia	Legnano	MI
Italy	P.O. Lentini - U.O. Di Cardiologia Con Utic	Lentini	SR
Italy	Nuovo Ospedale Versilia - Sc Cardiologia	Lido Di Camaiore	LU
Italy	Ics Maugeri Spa Societa' Benefit - U.O. Di Cardiologia Riabilitativa	Lumezzane	BS
Italy	Ospedale San Leopoldo Mandic - Cardiologia - Ucc	Merate	LC
Italy	Policlinico G. Martino - U.O. Medicina Interna	Messina	ME
Italy	Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica	Milano	MI
Italy	Asst Ospedale Metropolitano Niguarda - Cardiologia 2 -Insuff. Card. E Trapianto	Milano	MI
Italy	Asst Ospedale Metropolitano Niguarda - Diagnosi E Cure Terr. Malattie Cardiache	Milano	MI
Italy	Centro Cardiologico Monzino - Cardiologia D'Urgenza	Milano	MI
Italy	Ospedale San Carlo Borromeo - Cardiologia-Ucc	Milano	MI
Italy	Ospedale San Raffaele - Cardiologia Clinica	Milano	MI
Italy	Ospedale Civile - U.O. Cardiologia	Mirano	VE
Italy	Ospedale Santa Croce - Cardiologia	Moncalieri	TO
Italy	Ics Maugeri Spa Societa' Benefit - Divisione Di Cardiologia Riabilitativa	Montescano	PV
Italy	Ospedale San Gerardo - U.O. Cardiologia-Utic	Monza	MB
Italy	Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco	Monza	MB
Italy	Aou Federico Ii - Uoc Cardiologia E Utic	Napoli
Italy	Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic	Nola
Italy	Ospedale San Francesco - Cardiologia - Utic	Nuoro	NU
Italy	Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia	Orbassano	TO
Italy	Fondazione Irccs Policlinico San Matteo - Cardiologia	Pavia	PV
Italy	Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica	Pavia	PV
Italy	Azienda Ospedaliera Di Perugia - Cardiologia E Fisiopat. Cardiovascolare	Perugia	PG
Italy	Ex Ospedale Grocco - Unita' Operativa Cres	Perugia	PG
Italy	Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic	Pescia
Italy	Ospedale Civile Immacolata Concezione - Cardiologia E Utic	Piove Di Sacco	PD
Italy	Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare	Pisa	PI
Italy	Ospedale San Jacopo - U.O. Cardiologia	Pistoia
Italy	Ospedale Dell'Alta Val D'Elsa Uosd Cardiologia-Utic	Poggibonsi	SI
Italy	Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic	Pomezia	RM
Italy	Ospedale Di Pordenone - S.O.C. Cardiologia	Pordenone	PN
Italy	Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic	Ragusa	RG
Italy	Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia	Ravenna	RA
Italy	Arcispedale Santa Maria Nuova - S.C. Cardiologia	Reggio Emilia	RE
Italy	Presidio Ospedaliero Di Passirana - Uo Cardiologia Riabilitativa	Rho	MI
Italy	Ospedale G. Ceccarini - Cardiologia-Utic	Riccione	RN
Italy	Ospedale Infermi -U.O. Cardiologia	Rimini	RN
Italy	Ao San Giovanni Addolorata - Cardiologia E Riab. Cardiologica	Roma	RM
Italy	Clinica Citta' Di Roma - Cardiologia-Utic	Roma	RM
Italy	Ospedale San Camillo - Uoc Cardiologia 1	Roma	RM
Italy	Ospedale Santo Spirito - U.O.C. Di Cardiologia	Roma	RM
Italy	P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic	Roma	RM
Italy	Policlinico Casilino - U.O. Cardiologia	Roma	RM
Italy	Policlinico Umberto Primo - Malattie Cardiovascolari A	Roma	RM
Italy	Istituto Clinico Humanitas - U.O. Cardiologia Clinica	Rozzano	MI
Italy	Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Interventistica - Emodinamic	Salerno	SA
Italy	Ospedale G. Fracastoro - U.O.C. Di Cardiologia	San Bonifacio	VR
Italy	Ospedale Ave Gratia Plena - Uosd Riabilitazione Cardiologica	San Felice A Cancello	CE
Italy	Ospedale S. Anna - U.O.C. Di Cardiologia	San Fermo Della Battaglia	CO
Italy	Casa Di Salute Santa Lucia - U.O. Cardiologia	San Giuseppe Vesuviano
Italy	Ospedale San Giuseppe E Melorio U.O.C. Cardiologia Utic	Santa Maria Capua Vetere	CE
Italy	Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia	Saronno	VA
Italy	Ospedale Di Sassuolo - Cardiologia	Sassuolo	MO
Italy	Ospedale Bolognini - Cardiologia E Unita' Coronarica	Seriate	BG
Italy	Aou Senese Ospedale S. Maria Alle Scotte - U.O.C. Cardiologia Ospedaliera	Siena	SI
Italy	Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica	Teramo	TE
Italy	Maria Pia Hospital - Uo Medicina	Torino	TO
Italy	Ospedale Giovanni Bosco - Sc Cardiologia	Torino	TO
Italy	Ospedale Mauriziano Umberto I - Sc Cardiologia	Torino	TO
Italy	Ospedali Treviglio-Caravaggio - Cardiologia	Treviglio	BG
Italy	Ospedale Ca' Foncello - U.O.C. Cardiologia	Treviso	TV
Italy	Asui Trieste - S.C. Centro Cardiovascolare	Trieste	TS
Italy	Ospedali Riuniti - Osp. Cattinara - S.O.C. Cardiologia	Trieste	TS
Italy	Pou Santa Maria Della Misericordia - S.O.C. Cardiologia	Udine	UD
Italy	Ospedale Di Circolo E Fondazione Macchi - Cardiologia I	Varese	VA
Italy	Ospedale Civile G. Jazzolino - U.O. Cardiologia - Utic	Vibo Valentia	VV

Sponsors (1)

Lead Sponsor	Collaborator
Heart Care Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to current guideline	To assess number of patients managed and treated following the 2016 ESC Heart Failure Gudelines (acute HF, chronic HFrEF, chronic HFmrEF, chronic HFpEF).	Enrollment
Primary	Patients managed and treated following International Guideline	Patients treatment in phase 1 versus phase 3	24 months
Secondary	Mortality	Death from all-causes, for cardiovascular causes, for HF	12 months Follow-up
Secondary	Morbidity	Hospital admissions from all-causes, for cardiovascular causes, for HF	12 months Follow-up
Secondary	Indication to heart failure device implantation	The rate of patients with chronic HFrEF with an indication to ICD and/or CRT planned in clinical practice	Enrollement
Secondary	Prescription rate of disease modifying drugs	The rate of patients with HFrEF receiving all the drugs recommended by current guidelines: ACE-Is/ARBs, betablockers and MRAs, in the absence of specific contraindications/intolerance.	Enrollment
Secondary	Oral anticoagulation prescription in patients with AF	Rate of patients treated with oral anticoagulants in case of AF	Enrollment
Secondary	Use of ARNI	The rate of implementation of a new drug approach (ARNI) for patients with HF and EF =35%	Enrollment
Secondary	Creatinine and EF evaluation	The rate of CHF patients with an available measure of EF and of creatinine.	Enrollment