Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Procedure: ICD implantation
- Registration Number
- NCT06543446
- Lead Sponsor
- University of Rochester
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3290
- Age ≥ 18 years (no upper limit)
- Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
- Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT** for at least one month
- Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:
receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7)
• MADIT-ICD Benefit Score < 50 (per Figure 4)
- Existing ICD/CRT-D
- • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
- Acute MI within the past 3 calendar months
- Chronic renal failure requiring hemodialysis
- Coronary revascularization within the past 3 calendar months
- History of sustained VT or VF
- Known genetic cause of cardiomyopathy
- Life expectancy < 1 year
- Unable or unwilling to follow study protocol
- Inability to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICD implantation ICD implantation ICD implantation based on current guidelines
- Primary Outcome Measures
Name Time Method All-cause mortality through study completion, an average of 3.5 year Death from any cause
- Secondary Outcome Measures
Name Time Method Major adverse cardiovascular events through study completion, an average of 3.5 years First occurrence of hospitalization for one of the following: stroke, myocardiac infarction, device-related complications, ICD shocks.
Healthcare utilization through study completion, an average of 3.5 year 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
Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D) One year 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)
Quality of life, using the EuroQol-5 Dimension (EQ-5D) One year 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
Trial Locations
- Locations (13)
MaineHealth
🇺🇸Portland, Maine, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Rutgers
🇺🇸New Brunswick, New Jersey, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Northwell Health
🇺🇸New York, New York, United States
Nuvance Health Hudson Valley Cardiovascular Practice, PC
🇺🇸Poughkeepsie, New York, United States
Intermountain Health Care, Inc.
🇺🇸Salt Lake City, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Rochester
🇺🇸Rochester, New York, United States