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

Heart Failure Clinical Trial

— DERIVATE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03352648
• Other study ID #: R659/17-CCM698
• Status: Enrolling by invitation
• 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
• 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.

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Systolic Dysfunction
• Ventricular Dysfunction, Left

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