Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 760
- 试验地点
- 2
- 主要终点
- Death from any cause
研究概览
简要总结
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
详细描述
The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.
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
- None
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
- •NIDCM (idiopathic or familial)*
- •LVEF ≤35% and presence of fibrosis on CMR
- •Diagnostic CMR scan
- •Age ≥18 years
- •Written informed consent
- •Ability to give informed consent
排除标准
- •ICM [previous myocardial infarction, previous percutaneous coronary intervention]
- •Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy].
- •Myocarditis
- •Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
- •Severe renal insufficiency (creatinine clearance <30 mL/min)
- •Current pacemaker or defibrillator in situ
- •Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)
- •Renal impairment defined as an eGFR <30 milliliters
- •Age <18 years
- •Patients presenting with pregnancy
- •Patients without informed consent
- •Participation in another randomized trial
- •Life expectancy <2 years
结局指标
主要结局
Death from any cause
时间窗: Day 0
Death from any causes during follow-up - after discharge.
次要结局
未报告次要终点
研究者
Prof. Dr. med. Ingo Eitel
Director
University of Luebeck