Using Cardiovascular Magnetic Resonance Identified Fibrosis to Assess Sudden Cardiac Death Risk in Patients With Non-ischemic Dilated Cardiomyopathy and the Unknown Therapeutic Risk Reduction of Contemporary Heart Failure Medication and Implantable Cardioverter-Defibrillators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- all-cause mortality
研究概览
简要总结
Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate. Improved risk stratification is needed to select patients at highest risk.
Hypotheses: 1. In NICM patients with CMR detected myocardial fibrosis, ICD implantation reduces all-cause mortality compared to guideline-directed medical therapy (GDMT) only. 2. Myocardial fibrosis assessed by cardiac MRI (CMR) can be used to stratify patients according to risk for sudden cardiac death.
Study design: 1. Patients with myocardial fibrosis: Randomized controlled trial (RCT). 2. Patients without myocardial fibrosis: Prospective registry.
Study population: Patients with non-ischemic cardiomyopathy with LVEF <35% after at least 3 months of guideline-directed medical therapy (GDMT).
Intervention: ICD implantation. Main study parameters/endpoints: primary endpoint: all-cause mortality. Secondary endpoints include: patient clinical status, quality of life, sudden cardiac death, ventricular arrhythmias, ICD complications and ICD therapy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All ICDs that are implanted in the study are standard devices that are used in daily clinical practice. Patients who are randomized to ICD implantation will be subjected to the risk of perioperative and long-term complications but will be partly protected against death from ventricular arrhythmias. Patients randomized to no ICD implantation will not be protected against the residual risk of sudden cardiac death but are not subjected to complications from ICD implantation and possible subsequent complications. The only additional burden for patients is completing quality-of-life questionnaires, all hospital visits are for routine follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Non-ischemic cardiomyopathy
- •Left ventricular late gadolinium enhancement on MRI, but not hinge-point fibrosis
- •Left ventricular ejection fraction <35% on any modality
- •Functional class NYHA I-III
- •At least 3 months optimal medical treatment for heart failure
排除标准
- •Indication for cardiac resynchronization therapy
- •Functional class NYHA IV
- •Typical ischemic scar tissue on CMR
- •Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease
- •high-risk mutations causing DCM
- •Patient on waiting list for heart transplantation
- •Left ventricular assist device present
- •Severe valve disease
- •Secondary prevention indication for ICD
- •Untreated cardiac ischemia
- •High competing risk of death (>35% in 1 year according to HFmetascore)
- •Active chemotherapy for cancer
- •Severe renal failure with dialysis expected within 3 years
研究组 & 干预措施
guideline directed medical therapy
guideline directed medical therapy and ICD implantation
干预措施: ICD implantation (Device)
结局指标
主要结局
all-cause mortality
时间窗: 36 months
次要结局
- quality of life as measured by standardized questionnaires(36 months)
- ventricular arhythmias(36 months)
- sudden cardiac death(36 months)
- ICD-related complications(36 months)
- ICD therapy(36 months)