Clinical trial NCT03352648: CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)
Official title: CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Left Ventricular Systolic Dysfunction
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2017-11-24
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of patients at multiple international centers undergoing clinically-indicated cardiac magnetic resonance (CMR) as part of their standard of care.

Brief summary: The DERIVATE study was conceived to integrate the information resulted from clinical data, transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a more reliable risk stratification in patients affected by heart failure (HF) and worthy of prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and imaging score that effectively improves the selection of patients who deserve a prophylactic ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse cardiac events (MACE) as compared to standard clinical scores.

Detailed description: The current guidelines provide indications for primary prevention implanted cardioverter defibrillator (ICD) therapy based on left ventricle ejection fraction (LVEF) and New York Heart Association (NYHA) class. This strategy is able to intercept only part of fatal arrhythmic events and, on the other hand, led to useless ICD implantations mainly among those patients with severe heart failure (HF) who will never incur in sever arrhythmias but rather will die because of decompensated HF. Cardiac magnetic resonance offers the possibility of identifying and quantitatively assessing myocardium fibrosis both localized in a specific area and diffuse and has already proved a significant prognostic meaning. DERIVATE is a prospective, international, multicenter, observational registry of stable HF patients with reduced LVEF who underwent clinical evaluation, transthoracic echocardiography (TTE) and cardiac magnetic resonance (CMR). Specifically, the primary aim of DERIVATE is to determine CMR findings that predict outcomes, with incremental value over LVEF and NYHA classification.

The DERIVATE registry uses a collaborative design with contribution and merger of similar prospectively enrolled cohorts from 33 sites in 6 countries in Europe and North America. The targeted population for the DERIVATE registry is a large sample of patients with clinical history of chronic HF who have undergone CMR by referral physician. Indication for CMR exams was recorded and classified according to the known causes of HF. All DERIVATE study patients are followed for all-cause mortality, sudden cardiac death (SCD), cardiovascular death (including death caused by acute myocardial infarction and stroke), sustained ventricular tachycardia (VT), aborted SCD, hospitalization or cardiac death related to chronic HF. The follow up minimum period is 12 months. Complete risk factors, clinical presentation, echocardiography and CMR data recording, and follow-up for all-outcomes will contribute data for common analysis.

Eligibility criteria: Inclusion Criteria:

* Heart Failure patients (according to the ACC/AHA classification) with known ischemic cardiomyopathy (ICM) or non ischemic dilated cardiomyopathy (DCM)
* reduced left ventricle ejection fraction (LVEF) (\<50%)

Exclusion Criteria:

* pregnancy
* current alcohol or drug abuse
* unstable angina
* decompensated HF (NYHA class IV) in the previous 1 month
* acute myocarditis in the previous 3 months
* recent myocardial infarction (MI) (\<40 days) or)
* severe valvular disease
* cardiac amyloidosis
* hypertrophic cardiomyopathy
* arrhthmogenic right ventricular cardiomyopathy
* takotsubo cardiomyopathy
* congenital heart disease
* non CMR compatible device
* estimated glomerular filtration rate ≤30 mL/min/1.73m2
* other contraindication to gadolinium contrast agent
* severe claustrophobia
* participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies)
* unwilling or unable to provide informed consent.

Primary outcomes:
measure: all-cause mortality
timeFrame: The follow up minimum period is 12 months
Secondary outcomes:
measure: sudden cardiac death (SCD)
timeFrame: The follow up minimum period is 12 months
measure: aborted sudden cardiac death (SCD)
timeFrame: The follow up minimum period is 12 months
measure: heart failure (HF) death
timeFrame: The follow up minimum period is 12 months
measure: sustained ventricular tachycardia (VT)
timeFrame: The follow up minimum period is 12 months
measure: major adverse cardiac events (MACE)
timeFrame: The follow up minimum period is 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Loyola University of Chicago,
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Leuven
country: Belgium
facility: KU Leuven-University of Leuven
city: Thessaloníki
country: Greece
facility: St.Luke's Hospital Thessaloniki
city: Acerra
country: Italy
facility: Ospedale Medico-Chirurgico Accreditato Villa dei Fiori
city: Bari
country: Italy
facility: University Hospital Policlinico Consorziale
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Desio
country: Italy
facility: A.O. Desio e Vimercate - P.O. Desio
city: Foggia
country: Italy
facility: Ospedali Riuniti University Hospital
city: Messina
country: Italy
facility: University of Messina
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato,
city: Milano
country: Italy
facility: Vita-Salute San Raffaele University
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Padua
country: Italy
facility: University of Padua
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: Policlinico San Matteo Pavia Fondazione IRCCS
city: Pisa
country: Italy
facility: Fondazione G. Monasterio CNR, Regione Toscana
city: Rimini
country: Italy
facility: Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna
city: Roma
country: Italy
facility: Casilino Polyclinic
city: Roma
country: Italy
facility: Vannini Hospital Rome
city: Rome
country: Italy
facility: Sapienza University of Rome
city: Rozzano
country: Italy
facility: Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS,
city: Siena
country: Italy
facility: University of Siena
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital-CHUV
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: The Heart Hospital
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino, Milano, Italy
name: Gianluca Pontone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Policlinico Consorziale of Bari, Bari , Italy
name: Andrea Igoren Guaricci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland
name: Jurg Schwitter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland
name: Pier Giorgio Masci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guaricci AI, Masci PG, Muscogiuri G, Guglielmo M, Baggiano A, Fusini L, Lorenzoni V, Martini C, Andreini D, Pavon AG, Aquaro GD, Barison A, Todiere G, Rabbat MG, Tat E, Raineri C, Valentini A, Varga-Szemes A, Schoepf UJ, De Cecco CN, Bogaert J, Dobrovie M, Symons R, Focardi M, Gismondi A, Lozano-Torres J, Rodriguez-Palomares JF, Lanzillo C, Di Roma M, Moro C, Di Giovine G, Margonato D, De Lazzari M, Perazzolo Marra M, Nese A, Casavecchia G, Gravina M, Marzo F, Carigi S, Pica S, Lombardi M, Censi S, Squeri A, Palumbo A, Gaibazzi N, Camastra G, Sbarbati S, Pedrotti P, Masi A, Carrabba N, Pradella S, Timpani M, Cicala G, Presicci C, Puglisi S, Sverzellati N, Santobuono VE, Pepi M, Schwitter J, Pontone G. CarDiac magnEtic Resonance for prophylactic Implantable-cardioVerter defibrillAtor ThErapy in Non-Ischaemic dilated CardioMyopathy: an international Registry. Europace. 2021 Jul 18;23(7):1072-1083. doi: 10.1093/europace/euaa401.
citation: Guaricci AI, Masci PG, Lorenzoni V, Schwitter J, Pontone G. CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy international registry: Design and rationale of the DERIVATE study. Int J Cardiol. 2018 Jun 15;261:223-227. doi: 10.1016/j.ijcard.2018.03.043. Epub 2018 Mar 11.