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

Sponsor
Gianluca Pontone, MD, PhD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03352648
Collaborator
University of Lausanne Hospitals (Other)
4,000
Enrollment
29
Locations
167
Anticipated Duration (Months)
137.9
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry
    Actual Study Start Date :
    Jan 1, 2007
    Anticipated Primary Completion Date :
    Aug 1, 2019
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. all-cause mortality [The follow up minimum period is 12 months]

    Secondary Outcome Measures

    1. sudden cardiac death (SCD) [The follow up minimum period is 12 months]

    2. aborted sudden cardiac death (SCD) [The follow up minimum period is 12 months]

    3. heart failure (HF) death [The follow up minimum period is 12 months]

    4. sustained ventricular tachycardia (VT) [The follow up minimum period is 12 months]

    5. major adverse cardiac events (MACE) [The follow up minimum period is 12 months]

      composite end point of SCD, aborted SCD, cardiovascular death, and sustained VT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loyola University of Chicago, Chicago Illinois United States 60611
    2 Medical University of South Carolina Charleston South Carolina United States 29402
    3 KU Leuven-University of Leuven Leuven Belgium 3000
    4 St.Luke's Hospital Thessaloniki Thessaloníki Greece 57010
    5 Ospedale Medico-Chirurgico Accreditato Villa dei Fiori Acerra Italy 80121
    6 University Hospital Policlinico Consorziale Bari Italy 70122
    7 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24121
    8 A.O. Desio e Vimercate - P.O. Desio Desio Italy 20033
    9 Ospedali Riuniti University Hospital Foggia Italy 71100
    10 University of Messina Messina Italy 98121
    11 IRCCS Policlinico San Donato, Milano Italy 20097
    12 Vita-Salute San Raffaele University Milano Italy 20132
    13 Centro Cardiologico Monzino, IRCCS Milano Italy 20138
    14 IRCCS Istituto Auxologico Italiano Milano Italy 20149
    15 ASST Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    16 University of Padua Padua Italy 35128
    17 Azienda Ospedaliero-Universitaria di Parma Parma Italy 43126
    18 Policlinico San Matteo Pavia Fondazione IRCCS Pavia Italy 27100
    19 Fondazione G. Monasterio CNR, Regione Toscana Pisa Italy 56124
    20 Azienda Unità Sanitaria Locale di Rimini - Regione Emilia Romagna Rimini Italy 47924
    21 Casilino Polyclinic Roma Italy 00169
    22 Vannini Hospital Rome Roma Italy 00177
    23 Sapienza University of Rome Rome Italy 00185
    24 Humanitas Research Hospital, Hospital Care and Research Institution, IRCCS, Rozzano Italy 20089
    25 University of Siena Siena Italy 53100
    26 Lausanne University Hospital-CHUV Lausanne Switzerland CH-1015
    27 Bristol Heart Institute Bristol United Kingdom
    28 King's College London London United Kingdom
    29 The Heart Hospital London United Kingdom

    Sponsors and Collaborators

    • Gianluca Pontone, MD, PhD
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianluca Pontone, MD, PhD, Director of MR Unit & Deputy Director of Cardiovascular CT Unit, Centro Cardiologico Monzino
    ClinicalTrials.gov Identifier:
    NCT03352648
    Other Study ID Numbers:
    • R659/17-CCM698
    First Posted:
    Nov 24, 2017
    Last Update Posted:
    Jun 6, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:
    Heart Failure
    Ventricular Dysfunction, Left

    Study Results

    No Results Posted as of Jun 6, 2019