Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
研究概览
简要总结
Several attempts have been made to refine selection criteria for cardiac resynchronisation therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously proposed parameters probably do not sufficiently reflect the underlying mechanical dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that better candidate selection can rely on the direct observation or measurement of this LV mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate regional myocardial workload and metabolism, and determine their predictive value in CRT response.
研究设计
- 研究类型
- Interventional
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
- 未提供
排除标准
- •Impossible to obtain LV volumes by echocardiography.
- •Right bundle branch block.
- •Permanent atrial fibrillation, flutter or tachycardia (>100 bpm).
- •Recent myocardial infarction, within 40 days prior to enrolment.
- •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, women of child bearing potential.
- •Enrolled in one or more concurrent studies that would confound the results of this study.
结局指标
主要结局
Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
时间窗: Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation
Reduction in LVESV ≥15% from baseline
CRT response assessed by echocardiography
时间窗: Change of LVESV between baseline and 12 months after CRT implantation
Reduction in LVESV ≥15% from baseline
次要结局
- Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography(Change of remodelling between baseline, 6 and 12 months after CRT implantation)
- Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography(Change of remodelling between baseline, 6 and 12 months after CRT implantation)
- Quality of Life changes(Change of QoL between baseline, 6 and 12 months after CRT implantation)
- Heart failure related hospital admissions(Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation)
- New York Heart Association (NYHA) class changes(Change of NYHA class between baseline, 6 and 12 months after CRT implantation)
- Functional capacity changes assessed by 6-minute walking test(Change of functional capacity between baseline and 6 months after CRT implantation)
- Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)(Change of functional capacity between baseline and 6 months after CRT implantation)
- Death(Assessment of possible death at 6 and 12 months after CRT implantation)
研究者
prof. dr. Jens-Uwe Voigt
prof. dr.
Universitaire Ziekenhuizen KU Leuven