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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03352648 |
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Date of registration:
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21/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)
DERIVATE |
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Scientific title:
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CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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4000 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03352648 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Greece
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Italy
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Andrea Igoren Guaricci, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Policlinico Consorziale of Bari, Bari , Italy |
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Name:
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Pier Giorgio Masci, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland |
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Name:
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Gianluca Pontone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS Centro Cardiologico Monzino, Milano, Italy |
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Name:
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Jurg Schwitter, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Left Ventricular Systolic Dysfunction
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Primary Outcome(s)
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all-cause mortality
[Time Frame: The follow up minimum period is 12 months]
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Secondary Outcome(s)
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aborted sudden cardiac death (SCD)
[Time Frame: The follow up minimum period is 12 months]
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sustained ventricular tachycardia (VT)
[Time Frame: The follow up minimum period is 12 months]
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heart failure (HF) death
[Time Frame: The follow up minimum period is 12 months]
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major adverse cardiac events (MACE)
[Time Frame: The follow up minimum period is 12 months]
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sudden cardiac death (SCD)
[Time Frame: The follow up minimum period is 12 months]
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Secondary ID(s)
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R659/17-CCM698
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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