Contractile Reserve in Dyssynchrony (CRID): A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reverse remodelling at 6 months follow-up
研究概览
简要总结
Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT are non-responders. In this study the investigators will use a previously validated method to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and blood pressure. Furthermore, cardiac magnetic resonance imaging (CMR) with late gadolinium enhancement (LGE) will be performed in feasible subjects. The main purpose of the study is to determine if myocardial work by echocardiography in combination with viability assessment by LGE-CMR can predict response to CRT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is indicated for CRT device according to European Society of Cardiology (ESC) guidelines from
- •Subject is willing to sign informed consent form and is 18 years or older.
排除标准
- •Right bundle branch block.
- •Recent myocardial infarction, within 40 days prior to enrollment.
- •Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
- •Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- •Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
- •Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period).
- •Complex and uncorrected congenital heart disease.
- •Breastfeeding women or women of child bearing potential.
- •Enrolled in one or more concurrent studies that would confound the results of this study.
- •Impossible to obtain LV volumes by echocardiography
结局指标
主要结局
Reverse remodelling at 6 months follow-up
时间窗: 6 months
Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
次要结局
- New York Heart Association (NYHA) Class Changes(6 months)
- Death of any cause(5 years)
- Heart transplantation(5 years)
- Left atrial contractile synchrony(2 years)
- Heart failure hospitalizations(12 months)
- Reverse remodelling at 12 months follow-up(12 months)
- Quality of Life Changes(6 months)
研究者
Otto Armin Smiseth
Professor
Oslo University Hospital