Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
研究概览
简要总结
Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.
The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.
This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients must have an indication for ICD therapy
- •Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction < 35% and LV cavity dilatation (end diastolic dimension > 55 mm)
- •NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
- •QRS duration ≥120ms
排除标准
- •Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
- •Requirement for ventricular pacing due to atrioventricular block.
- •Limited life expectancy (< 6 months)
结局指标
主要结局
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
时间窗: 6 months
次要结局
- Change in New York Heart Association (NYHA) class from baseline to 6 months(6 months)
- Change in Quality-of-Life score from baseline to 6 months(6 months)
- Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR(6 months)