Welcome to CONTEMP-ICD
Thank you for your interest in CONTEMP-ICD. In this study, individuals with heart failure with reduced ejection fraction (HFrEF) are partnering with doctors and research teams to advance our understanding of the effectiveness of contemporary guideline-directed medical therapy (GDMT) compared to the use of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death. Through this collaborative effort, we aim to improve patient outcomes and optimize treatment strategies for heart failure.
Why This Study is Important?
Having heart failure with reduced ejection fraction (HFrEF) puts you at significant risk for sudden cardiac death.
While implantable cardioverter defibrillators (ICDs) have traditionally been used for primary prevention, advances in guideline-directed medical therapy (GDMT) have greatly improved outcomes for HFrEF patients. It is not known if contemporary GDMT alone is as effective as ICDs in reducing mortality and major cardiovascular events in patients with low predicted arrhythmic risk. This study aims to determine the effectiveness of GDMT compared to ICD implantation, potentially leading to more personalized and optimized treatment strategies for HFrEF patients.
How the Study Works?
If you choose to participate, you will be randomly assigned to one of two groups for treatment:
Our study team will work with your regular healthcare provider to ensure that the assigned treatment fits into your usual heart failure care. Your current medications and treatment regimen may be adjusted to optimize your heart failure management.
Study Eligibility
CONTEMP-ICD may be for you if you meet the following criteria:
Age:
Participants must be 18 years or older.
Heart Failure:
Must have ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction (LVEF) of ≤35% after being stable on optimal guideline-directed medical therapy (GDMT) for at least one month.
ICD Indication:
Must have a Class I or IIa indication for a primary prevention ICD per current guidelines
MADIT-ICD Benefit Score:
Must have a MADIT-ICD Benefit Score of < 50.
Willingness:
Must be willing and able to receive an ICD if randomized to the ICD arm.