NCT02434159Unknown不适用
Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 6 minute walk test
研究概览
简要总结
The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.
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
- None
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
- •Age > 18, <90
- •Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
- •QRS duration >120ms on 12 lead ECG
- •LVEF < 35%
- •LVEDD >55 mm
- •Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.
排除标准
- •Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
- •Patients who had had an atrial arrhythmia within one month prior to recruitment
- •Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
- •Patients with a heart rate of more than 140 beats per minute
- •Patients with severe renal failure (eGFR < 30)
- •Patients with a history of allergy to iodine based contrast agents
- •Predicted life expectancy < 1 year
研究组 & 干预措施
Scan
Active Comparator
Heart scan prior to device insertion
干预措施: Heart scan (Other)
No scan
No Intervention
No heart scan prior to device insertion
结局指标
主要结局
6 minute walk test
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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