Heart FailureDERIVATENCT03352648
CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)
An observational study of Heart Failure and Left Ventricular Systolic Dysfunction, run by Gianluca Pontone, MD, PhD at 29 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Left Ventricular Systolic Dysfunction
- How many people
- 4,000 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Jan 2007to Dec 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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%)
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
Italy21 sites
Ospedale Medico-Chirurgico Accreditato Villa dei Fiori
Acerra, 80121
University Hospital Policlinico Consorziale
Bari, 70122
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24121
A.O. Desio e Vimercate - P.O. Desio
Desio, 20033
Ospedali Riuniti University Hospital
Foggia, 71100
University of Messina
Messina, 98121
IRCCS Policlinico San Donato,
Milan, 20097
Vita-Salute San Raffaele University
Milan, 20132
Centro Cardiologico Monzino, IRCCS
Milan, 20138
IRCCS Istituto Auxologico Italiano
Milan, 20149
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
University of Padua
Padua, 35128
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, 27100
Fondazione G. Monasterio CNR, Regione Toscana
Pisa, 56124
Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna
Rimini, 47924
Casilino Polyclinic
Roma, 00169
Vannini Hospital Rome
Roma, 00177
Sapienza University of Rome
Rome, 00185
Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS,
Rozzano, 20089
University of Siena
Siena, 53100
United Kingdom3 sites
Bristol Heart Institute
Bristol
King's College London
London
The Heart Hospital
London
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29402
Loyola University of Chicago,
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: The follow up minimum period is 12 months
Secondary outcomes (5)
sudden cardiac death (SCD)
Measured: The follow up minimum period is 12 months
aborted sudden cardiac death (SCD)
Measured: The follow up minimum period is 12 months
heart failure (HF) death
Measured: The follow up minimum period is 12 months
sustained ventricular tachycardia (VT)
Measured: 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
Measured: The follow up minimum period is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startJan 2007
- Primary completionAug 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gianluca Pontone, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino
- Investigators
- Gianluca Pontone, MD, Principal investigator, IRCCS Centro Cardiologico Monzino, Milano, ItalyAndrea Igoren Guaricci, MD, Principal investigator, University Hospital Policlinico Consorziale of Bari, Bari , ItalyJurg Schwitter, MD, Principal investigator, Lausanne University Hospital-CHUV, Lausanne, Vaud, SwitzerlandPier Giorgio Masci, MD, Principal investigator, Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352648
- Sponsor's protocol ID
- R659/17-CCM698
- Acronym
- DERIVATE
- Status last verified
- Jun 2019
- First submitted
- 21 Nov 2017
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muscogiuri G, Guaricci AI, Fusini L, Senatieri A, Abete R, Aquaro GD, Baggiano A, Barison A, Bogaert J, Calo' L, Camastra G, Carella MC, Carigi S, Carrabba N, Casavecchia G, Censi S, Cicala G, De Cecco CN, Ciccone MM, De Lazzari M, Di Giovine G, Dobrovie M, Focardi M, Gaibazzi N, Gismondi A, Gravina M, Guglielmo M, Lanzillo C, Lombardi M, Lorenzoni V, Lozano-Torres J, Margonato D, Martini C, Marzo F, Masci PG, Masi A, Moro C, Mushtaq S, Nese A, Palumbo A, Pavon AG, Pedrotti P, Marra MP, Pradella S, Presicci C, Rabbat MG, Raineri C, Rodriguez-Palomares JF, Sbarbati S, Varga-Szemes A, Squeri A, Sverzellati N, Symons R, Tat E, Timpani M, Todiere G, Valentini A, Volpe A, Sironi S, Schwitter J, Pontone G. CarDiac magnEtic resonance for prophylactic implantable cardioVerter defibrillAtor ThErapy in ischemic dilated CardioMyopathy: Prognostic implication of papillary muscles involvement. Prog Cardiovasc Dis. 2026 Apr 19:S0033-0620(26)00034-4. doi: 10.1016/j.pcad.2026.04.005. Online ahead of print.
PubMed 42013967Ghanbari 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.
PubMed 36943075Guaricci 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.
PubMed 33792661Guaricci 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.
PubMed 29550015