Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- ventricular tachyarrhytmia
研究概览
简要总结
The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.
详细描述
Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
- •LVD d/t MI, LVEF 30% to 35%, NYHA II, III
- •LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
- •LVD d/t MI, LVEF 30% or less, NYHA I
- •NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
- •NICM, LVEF 30% to 35%, NYHA II, III
- •NICM, LVEF 30% or less, NYHA I
- •signed informed consent
排除标准
- •metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- •severe claustrophobia may not be able to tolerate an MRI scan
- •heart rhythm device in place before enrollment
- •atrial fibrillation in time of enrollment
- •ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
- •NYHA or CCS class IV
- •PCI or CABG in last 3 months
- •CMP/TIA in last 3 months
- •syncope of unknown etiology
结局指标
主要结局
ventricular tachyarrhytmia
时间窗: 36 months
ventricular tachycardia equal or \> 250/min,ventricular fibrillation, arrhythmic storm
次要结局
- sudden cardiac death(36-months)