The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).
The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events. This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,290
Surgical implant of ICD device
MaineHealth
Portland, Maine, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
All-cause mortality
Death from any cause
Time frame: through study completion, an average of 3.5 year
Major adverse cardiovascular events
First occurrence of hospitalization for one of the following: stroke, myocardiac infarction, device-related complications, ICD shocks.
Time frame: through study completion, an average of 3.5 years
Healthcare utilization
Total number of the following events during following: all-cause hospital admissions, emergency department visits, planned and unplanned clinic visits. All events will be captured from electronic medical records
Time frame: through study completion, an average of 3.5 year
Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D)
Kansas City Cardiomyopathy Questionnaire \[KCCQ\] (the KCCQ ranges from 0 to 100, with 0 representing the worst possible health status and 100) and EuroQol-5 Dimension (EQ-5D) (Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state)
Time frame: One year
Quality of life, using the EuroQol-5 Dimension (EQ-5D)
Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state
Time frame: One year
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RECRUITINGCorewell Health
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