Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 36
- 主要终点
- Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia
研究概览
简要总结
Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention implantable defibrillator (ICD) in patients with left ventricular ejection fraction less than 35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that these patients have ventricular scar and/or replacement fibrosis as a substrate for their malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).
Methods/Design: A multi-centre randomised controlled trial in which 428 patients with mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or implantable loop recorder (ILR) insertion and are followed up until the last patient recruited has been in the study for 3 years.
Potentially eligible patients will have a screening CMR and will be enrolled into the device arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do not have ventricular scar/fibrosis will be followed up in an observational registry, and will not be randomised.
In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in Europe.
The primary hypothesis is that among patients with mild-moderate left ventricular systolic dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a conservative strategy of standard care.
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 equal or greater than 18 years
- •Patients with coronary artery disease (CAD) or dilated cardiomyopathy (DCM) of the idiopathic, chronic post myocarditis or familial type.
- •Left ventricular systolic impairment as defined by left ventricular ejection fraction 36-50% by any current standard technique (echocardiogram, multiple gated acquisition scan (MUGA), angiography or CMR taken in the last six months. If a LGE CMR has been taken within 2 months this scan can be used for inclusion
- •Able and willing to comply with all pre-, post- and follow-up testing, and requirements
- •On maximum tolerated doses of ACE inhibitors (or Angiotensin and Receptor Blockers if intolerant of ACE) and Beta Blockers
排除标准
- •History of cardiac arrest or spontaneous or inducible sustained ventricular tachycardia or ventricular fibrillation unless within 48 hours of an acute MI
- •Cardiomyopathy related to sarcoidosis
- •Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe claustrophobia)
- •Currently implanted permanent pacemaker and/or pacemaker/ICD lead
- •Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy.
- •CMR LVEF ≤35% or>50%
- •Severe renal insufficiency (eGFR< 30mls/min/1.73m2)
- •Recent Myocardial Infarction (MI) (<40 days) or cardiac revascularization (<90 days)
- •New York Heart Association HF functional class IV at baseline
- •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
Observational Registry
A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR
Device Implantation
A prospective, blocked, randomised, placebo-controlled trial of primary prophylaxis ICD therapy or implantable loop recorder (ILR) insertion in patients with LVEF 36-50% and Late Gadolinium Enhancement(LGE)on CMR
干预措施: ICD (Device)
Device Implantation
A prospective, blocked, randomised, placebo-controlled trial of primary prophylaxis ICD therapy or implantable loop recorder (ILR) insertion in patients with LVEF 36-50% and Late Gadolinium Enhancement(LGE)on CMR
干预措施: ILR (Device)
结局指标
主要结局
Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia
时间窗: Through to study completion, an average of 4 years
Defined as: ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP\<90mmHg) except directly associated with device implant procedure.
次要结局
- Sudden Cardiac Death(Through to study completion, an average of 4 years)
- Haemodynamically significant ventricular arrhythmia(Through to study completion, an average of 4 years)
- All-cause mortality(Through to study completion, an average of 4 years)
- Change in New York Heart Association Functional class(3, 6,12, 24, 36, 48 months)
- Health economic evaluation of cost(At study completion, average of 4 years)
- Quality of life assessed by Minnesota Living with Heart Failure Questionnaire(3, 6,12, 24, 36, 48 months)
- Heart failure related hospitalizations(Through to study completion, an average of 4 years)
- Quality of life assessed by EuroQol-5D-5L questionnaire(3, 6,12, 24, 36, 48 months)
研究者
Joseph Selvanayagam
Professor Joseph Selvanayagam
Flinders University