CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)

Status unconfirmed

Conditions studied: Heart Failure, Left Ventricular Systolic Dysfunction

In brief

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.

Key facts

Study ID

NCT03352648

Run by

Gianluca Pontone, MD, PhD

People needed

4000

Starts

2007-01-01

Expected to finish

2020-12-01

Last updated by the study team

2019-06-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%)

You may not qualify if…

• 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.

Where it is running

• Loyola University of Chicago, — Chicago, Illinois, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• KU Leuven-University of Leuven — Leuven, Belgium
• St.Luke's Hospital Thessaloniki — Thessaloniki, Greece
• Ospedale Medico-Chirurgico Accreditato Villa dei Fiori — Acerra, Italy
• University Hospital Policlinico Consorziale — Bari, Italy
• Azienda Ospedaliera Papa Giovanni XXIII — Bergamo, Italy
• A.O. Desio e Vimercate - P.O. Desio — Desio, Italy
• Ospedali Riuniti University Hospital — Foggia, Italy
• University of Messina — Messina, Italy
• IRCCS Policlinico San Donato, — Milan, Italy
• Vita-Salute San Raffaele University — Milan, Italy
• Centro Cardiologico Monzino, IRCCS — Milan, Italy
• IRCCS Istituto Auxologico Italiano — Milan, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
• University of Padua — Padua, Italy
• Azienda Ospedaliero-Universitaria di Parma — Parma, Italy
• Policlinico San Matteo Pavia Fondazione IRCCS — Pavia, Italy
• Fondazione G. Monasterio CNR, Regione Toscana — Pisa, Italy
• Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna — Rimini, Italy
• Casilino Polyclinic — Roma, Italy
• Vannini Hospital Rome — Roma, Italy
• Sapienza University of Rome — Rome, Italy
• Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS, — Rozzano, Italy
• University of Siena — Siena, Italy

Full record on ClinicalTrials.gov

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