Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 61
- 主要终点
- Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
研究概览
简要总结
Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%
详细描述
Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for SCD prevention in patients with non-ischemic dilated cardiomyopathy with LVEF≤35%
Randomization will be 1:1 and patients are allocated to either control strategy or intervention strategy.
In the control strategy group, patients will get an Implantable Cardioverter Defibrillator (ICD) implanted. Patients allocated to the intervention strategy will receive an ICD according to genetic and CMR results. ICD implantation criteria in patients allocated to the personalised strategy group will be the presence of either a Dilated Cardiomyopathy DCM-causing pathogenic or likely pathogenic genetic variants or Late Gadolinium Enhancement (LGE) in Cardiac Magnetic Resonance (CMR). Patients without DCM-associated genetic variants and without LGE on CMR will not receive standard treatment but an ICD will not be implanted on them.
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 ≥ 18 years at the time of screening.
- •Previously established diagnosis of Non-ischemic DCM
- •Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.
- •NYHA functional class II-III.
- •LVEF ≤ 35% documented by CMR as study procedure.
- •Life expectancy greater than 12 months.
排除标准
- •History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)
- •Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.
- •Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
- •History of recovered sudden death or sustained ventricular tachycardia.
- •NYHA functional class IV.
- •Waiting list for cardiac transplantation in emergency
- •Receiver of a solid organ transplant (lung, liver, heart or kidney).
研究组 & 干预措施
Control Strategy
干预措施: Control Strategy (Other)
Personalized precision ICD implantation Strategy based in genetic findings and CMR results
干预措施: Personalized precision ICD implantation Strategy based in genetic findings and CMR results (Other)
结局指标
主要结局
Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
时间窗: 4 years
次要结局
- All-cause death(4 years)
- SCD(4 years)
- Quality of life assessed by KCCQ, EQ-5D and HADS(4 years)
- Hospitalisation for device-related complications(4 years)
- Non-fatal major arrhythmic events(4 years)
- cost-effectiveness(4 years)