Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Implantable cardioverter defibrillator, Sudden cardiac death, guideline directed medical therapy
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.
Interventions
PROCEDUREICD implantation
Surgical implant of ICD device
Sponsors
University of Rochester
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | through study completion, an average of 3.5 year | Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORIlan Goldenberg, MD
Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
Outcome results
None listed