Heart Failure Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

4000

Study ID:

NCT03352648

Recruitment Status:

Unknown status

Sponsor:

Gianluca Pontone, MD, PhD

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There are 26 Locations for this study

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Loyola University of Chicago,
Chicago Illinois, 60611, United States
Medical University of South Carolina
Charleston South Carolina, 29402, United States
KU Leuven-University of Leuven
Leuven , 3000, Belgium
St.Luke's Hospital Thessaloniki
Thessaloníki , 57010, Greece
Ospedale Medico-Chirurgico Accreditato Villa dei Fiori
Acerra , 80121, Italy
University Hospital Policlinico Consorziale
Bari , 70122, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo , 24121, Italy
A.O. Desio e Vimercate - P.O. Desio
Desio , 20033, Italy
Ospedali Riuniti University Hospital
Foggia , 71100, Italy
University of Messina
Messina , 98121, Italy
IRCCS Policlinico San Donato,
Milano , 20097, Italy
Vita-Salute San Raffaele University
Milano , 20132, Italy
Centro Cardiologico Monzino, IRCCS
Milano , 20138, Italy
IRCCS Istituto Auxologico Italiano
Milano , 20149, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
University of Padua
Padua , 35128, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma , 43126, Italy
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia , 27100, Italy
Fondazione G. Monasterio CNR, Regione Toscana
Pisa , 56124, Italy
Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna
Rimini , 47924, Italy
Casilino Polyclinic
Roma , 00169, Italy
Vannini Hospital Rome
Roma , 00177, Italy
Sapienza University of Rome
Rome , 00185, Italy
Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS,
Rozzano , 20089, Italy
University of Siena
Siena , 53100, Italy
Lausanne University Hospital-CHUV
Lausanne , CH-10, Switzerland
Bristol Heart Institute
Bristol , , United Kingdom
King's College London
London , , United Kingdom
The Heart Hospital
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

4000

Study ID:

NCT03352648

Recruitment Status:

Unknown status

Sponsor:


Gianluca Pontone, MD, PhD

How clear is this clinincal trial information?

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