Clinical trial NCT06543446: Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Official title: Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Implantable cardioverter defibrillator
Sudden cardiac death
guideline directed medical therapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-08-09
Enrollment: 3290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: through study completion, an average of 3.5 year
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: through study completion, an average of 3.5 years
measure: Healthcare utilization
timeFrame: through study completion, an average of 3.5 year
measure: Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D)
timeFrame: One year
measure: Quality of life, using the EuroQol-5 Dimension (EQ-5D)
timeFrame: One year
Other outcomes:
Locations:
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Northwell Health
state: New York
city: Poughkeepsie
country: United States
facility: Nuvance Health Hudson Valley Cardiovascular Practice, PC
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Salt Lake City
country: United States
facility: Intermountain Health Care, Inc.
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
name: Ilan Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiuzat M, Hamo CE, Butler J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O'Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.