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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Left Ventricular Systolic Dysfunction

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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KU Leuven-University of Leuven
• Greece
  • Thessaloníki, Greece, 57010
    • St.Luke's Hospital Thessaloniki
• Italy
  • Acerra, Italy, 80121
    • Ospedale Medico-Chirurgico Accreditato Villa dei Fiori
  • Bari, Italy, 70122
    • University Hospital Policlinico Consorziale
  • Bergamo, Italy, 24121
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Desio, Italy, 20033
    • A.O. Desio e Vimercate - P.O. Desio
  • Foggia, Italy, 71100
    • Ospedali Riuniti University Hospital
  • Messina, Italy, 98121
    • University of Messina
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20097
    • IRCCS Policlinico San Donato,
  • Milano, Italy, 20132
    • Vita-Salute San Raffaele University
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino, IRCCS
  • Milano, Italy, 20149
    • IRCCS Istituto Auxologico Italiano
  • Padua, Italy, 35128
    • University of Padua
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma
  • Pavia, Italy, 27100
    • Policlinico San Matteo Pavia Fondazione IRCCS
  • Pisa, Italy, 56124
    • Fondazione G. Monasterio CNR, Regione Toscana
  • Rimini, Italy, 47924
    • Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna
  • Roma, Italy, 00169
    • Casilino Polyclinic
  • Roma, Italy, 00177
    • Vannini Hospital Rome
  • Rome, Italy, 00185
    • Sapienza University of Rome
  • Rozzano, Italy, 20089
    • Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS,
  • Siena, Italy, 53100
    • University of Siena
• Switzerland
  • Lausanne, Switzerland, CH-1015
    • Lausanne University Hospital-CHUV
• United Kingdom
  • Bristol, United Kingdom
    • Bristol Heart Institute
  • London, United Kingdom
    • King's College London
  • London, United Kingdom
    • The Heart Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Loyola University of Chicago,
  • South Carolina
    • Charleston, South Carolina, United States, 29402
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	The follow up minimum period is 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sudden cardiac death (SCD)		The follow up minimum period is 12 months
aborted sudden cardiac death (SCD)		The follow up minimum period is 12 months
heart failure (HF) death		The follow up minimum period is 12 months
sustained ventricular tachycardia (VT)		The follow up minimum period is 12 months
major adverse cardiac events (MACE)	composite end point of SCD, aborted SCD, cardiovascular death, and sustained VT	The follow up minimum period is 12 months

Collaborators and Investigators

• Sponsor: Gianluca Pontone, MD, PhD
• Collaborators: University of Lausanne Hospitals
• Investigators: Principal Investigator: Gianluca Pontone, MD, IRCCS Centro Cardiologico Monzino, Milano, Italy; Principal Investigator: Andrea Igoren Guaricci, MD, University Hospital Policlinico Consorziale of Bari, Bari , Italy; Principal Investigator: Jurg Schwitter, MD, Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland; Principal Investigator: Pier Giorgio Masci, MD, Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Failure; Ventricular Dysfunction, Left
• Other Study ID Numbers: R659/17-CCM698