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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03352648
Other study ID # R659/17-CCM698
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 2007
Est. completion date December 2020

Study information

Verified date June 2019
Source Centro Cardiologico Monzino
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 4000
Est. completion date December 2020
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium KU Leuven-University of Leuven Leuven
Greece St.Luke's Hospital Thessaloniki Thessaloníki
Italy 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 ASST Grande Ospedale Metropolitano Niguarda Milano
Italy Centro Cardiologico Monzino, IRCCS Milano
Italy IRCCS Istituto Auxologico Italiano Milano
Italy IRCCS Policlinico San Donato, Milano
Italy Vita-Salute San Raffaele University Milano
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
Switzerland Lausanne University Hospital-CHUV Lausanne
United Kingdom Bristol Heart Institute Bristol
United Kingdom King's College London London
United Kingdom The Heart Hospital London
United States Medical University of South Carolina Charleston South Carolina
United States Loyola University of Chicago, Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Gianluca Pontone, MD, PhD University of Lausanne Hospitals

Countries where clinical trial is conducted

United States,  Belgium,  Greece,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause mortality The follow up minimum period is 12 months
Secondary sudden cardiac death (SCD) The follow up minimum period is 12 months
Secondary aborted sudden cardiac death (SCD) The follow up minimum period is 12 months
Secondary heart failure (HF) death The follow up minimum period is 12 months
Secondary sustained ventricular tachycardia (VT) The follow up minimum period is 12 months
Secondary 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
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