Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 41
- 主要终点
- Volume response and Packer Clinical Composite Score
研究概览
简要总结
Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.
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
- Double (Participant, Outcomes Assessor)
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
- •(- - - - - - - - - Inclusion Criteria - - - - - - - - -)
- •The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2021 guidelines. In addition:
- •Patient has a LVEF ≤ 35%
- •Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f)
- •Patient has been in a stable medical condition for ≥ 1 month prior inclusion
- •Patient underwent complete revascularization in case of ischemia
- •Patients is able to understand and willing to provide a written informed consent
- •Patient is 18 years or older
- •(- - - - - - - - -
排除标准
- •- - - - - - - -)
- •Patients with the following conditions will be excluded:
- •unreliable left ventricular volume measurements
- •severe MR or more than moderate other valvular disease
- •pulmonary hypertension, other than secondary to left heart disease
- •patient on hemodialysis
- •life expectancy < 1 year
- •pregnant or breastfeeding
- •Patients with prior right ventricular pacing between 20% to 80% will be excluded.
- •Patients with prior right ventricular pacing ≤ 20% or no pacemaker / ICD will be excluded if they have any of the following criteria:
- •PR duration > 250ms
- •second / third degree atrioventricular block
- •intrinsic QRS duration < 130ms
- •atrial fibrillation with resting HR < 50/min or > 80/min
- •Patients with prior right ventricular pacing ≥ 80% will be excluded if they have any of the following criteria:
- •sensed AV delay > 250ms
- •paced AV delay > 280ms
- •Patients with a prior pacemaker / ICD scheduled for LBBaP will be excluded regardless of pacing percentage
研究组 & 干预措施
Treatment recommendation based on guidelines
Treatment of the patient assigned to this arm will be based on the current guidelines for CRT implantation, as issued by the European Society of Cardiology. All patients will receive CRT implantation, with bi-ventricular pacing ON.
干预措施: Cardiac resynchronization therapy ON (Device)
Treatment recommendation based on mechanical dyssynchrony
Treatment of the patients assigned to this arm will be based on the presence of mechanical dyssynchrony. All patients will receive CRT implantation. Bi-ventricular pacing will be either turned ON or OFF, based on respectively the presence or absence of mechanical dyssynchrony.
干预措施: Cardiac resynchronization therapy ON (Device)
Treatment recommendation based on mechanical dyssynchrony
Treatment of the patients assigned to this arm will be based on the presence of mechanical dyssynchrony. All patients will receive CRT implantation. Bi-ventricular pacing will be either turned ON or OFF, based on respectively the presence or absence of mechanical dyssynchrony.
干预措施: Cardiac resynchronization therapy OFF (Device)
结局指标
主要结局
Volume response and Packer Clinical Composite Score
时间窗: 12 months follow-up
Non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in left ventricular end-systolic volume and the proportion of patients 'worsened' according to the Packer Clinical Composite Score after 12 months follow-up.
次要结局
- Difference in predictive value for volume response(12 months follow-up)
- Difference in long-term patient outcome in both arms(3 years and 5 years follow-up)
- Effect on left ventricular function in both arms(12 months follow-up)
- Difference in predictive value for long-term patient outcome in both arms(1 year, 3 years and 5 years follow-up)
- Difference in quality of life as measured by the Minnesota Living with Heart Failure questionnaire score and EuroQol 5D index score in both arms(12 months follow-up)
- Difference in 6 minute walk test distance in both arms(12 months follow-up)
研究者
Jens-Uwe Voigt, MD, PhD
Principle Investigator
Universitaire Ziekenhuizen KU Leuven