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

NCT ID: NCT03352648

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Heart Failure; Left Ventricular Systolic Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Gianluca Pontone, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Pontone, MD, PhD

Director of MR Unit & Deputy Director of Cardiovascular CT Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gianluca Pontone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro Cardiologico Monzino, Milano, Italy

Andrea Igoren Guaricci, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Policlinico Consorziale of Bari, Bari , Italy

Jurg Schwitter, MD

Role: PRINCIPAL_INVESTIGATOR

Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland

Pier Giorgio Masci, MD

Role: PRINCIPAL_INVESTIGATOR

Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland

Locations

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

Lausanne University Hospital-CHUV

Lausanne, , Switzerland

Bristol Heart Institute

Bristol, , United Kingdom

King's College London

London, , United Kingdom

The Heart Hospital

London, , United Kingdom

Countries

United States; Belgium; Greece; Italy; Switzerland; United Kingdom

References

Ghanbari F, Joyce T, Lorenzoni V, Guaricci AI, Pavon AG, Fusini L, Andreini D, Rabbat MG, Aquaro GD, Abete R, Bogaert J, Camastra G, Carigi S, Carrabba N, Casavecchia G, Censi S, Cicala G, De Cecco CN, De Lazzari M, Di Giovine G, Di Roma M, Focardi M, Gaibazzi N, Gismondi A, Gravina M, Lanzillo C, Lombardi M, Lozano-Torres J, Masi A, Moro C, Muscogiuri G, Nese A, Pradella S, Sbarbati S, Schoepf UJ, Valentini A, Crelier G, Masci PG, Pontone G, Kozerke S, Schwitter J. AI Cardiac MRI Scar Analysis Aids Prediction of Major Arrhythmic Events in the Multicenter DERIVATE Registry. Radiology. 2023 May;307(3):e222239. doi: 10.1148/radiol.222239. Epub 2023 Mar 21.

Reference Type: DERIVED

PMID: 36943075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33792661 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29550015 (View on PubMed)

Other Identifiers

R659/17-CCM698

Identifier Type: -

Identifier Source: org_study_id