Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3,290
- 试验地点
- 27
- 主要终点
- All-cause mortality
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
No-ICD implantation
No-ICD implantation despite current recommendation
ICD implantation
ICD implantation based on current guidelines
干预措施: ICD implantation (Procedure)
结局指标
主要结局
All-cause mortality
时间窗: through study completion, an average of 3.5 year
Death from any cause
次要结局
- Major adverse cardiovascular events(through study completion, an average of 3.5 years)
- Healthcare utilization(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)(One year)
- Quality of life, using the EuroQol-5 Dimension (EQ-5D)(One year)
研究者
Ilan Goldenberg
Professor of Medicine
University of Rochester