Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,880
- 主要终点
- All-Cause Mortality
研究概览
简要总结
CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.
Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).
954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).
Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.
详细描述
The planned research will have two components: A prospective, blocked, randomized, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and Late Gadolinium Enhancement (LGE) on CMR and
A prospective observational registry of patients with LVEF <45% and no LGE on CMR. Registry patients will not have an intervention but will have the same follow up frequency as the randomized patients.
The Primary objective is to determine if routine CMR guided management strategy of implantable defibrillator (ICD) insertion reduces total mortality compared to a conservative strategy of implantable loop recorder (ILR) insertion and standard care.
The secondary objectives include:
- To determine if routine CMR guided management strategy of ICD insertion reduces sudden cardiac death (SCD) compared to a conservative strategy of ILR insertion and standard care.
- To ascertain the rate of SCD in patients with DCM and LGE scar across a wide range of left ventricular ejection fraction (LVEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age greater than/equal to 18 years old
- •Non-ischemic cardiomyopathy of dilated type
- •Left Ventricular Ejection Fraction < 45%
- •Able and willing to comply with all pre, post and follow-up testing and requirements
- •On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers
排除标准
- •Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)
- •Hypertrophic Cardiomyopathy
- •Cardiomyopathy related to sarcoidosis
- •Arrhythmogenic Right Ventricular Dysplasia
- •Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)
- •Currently implanted permanent pacemaker and/or pacemaker/ICD lead
- •Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy
- •Contraindications to intravenous Gadolinium
- •Severe renal insufficiency (eGFR< 45mls/min/1.73m2 )
- •New York Heart Association Heart Failure functional class IV
- •Conditions associated with life expectancy <1 year
- •Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception
研究组 & 干预措施
Device Implantation
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
干预措施: ICD (Device)
Device Implantation
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
干预措施: ILR (Device)
Observational Registry
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
结局指标
主要结局
All-Cause Mortality
时间窗: Through to study completion, an average of 4 years
次要结局
- Number of Participants who have a Haemodynamically significant ventricular arrhythmia event(Through to study completion, an average of 4 years)
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire(Measured at 3, 6, 12, 24, 36 months through to study completion)
- Number of Participants who have a Heart Failure related hospitalisation(Through to study completion, an average of 4 years)
- Number of Participants who have Sudden Cardiac Death(Through to study completion, an average of 4 years)
- Health economic evaluation of cost(At study completion, an average of 4 years)
研究者
Joseph Selvanayagam
Principal Investigator
Flinders University