CompaRative Study of the Effects of Left ventriculAr and Biventricular Pacing on inDices of cArdiac Function and Clinical Course of Heart Failure PatienTs: Rationale and Design of the READAPT Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Changes in patient exercise capacity
研究概览
简要总结
Randomized trial of adult patients to study the effects of preferential left ventricular pacing on ventriculoarterial coupling of both systemic and pulmonary circulation, indices of systolic and diastolic function of both ventricles, and clinical course of patients with advances dyssynchronous heart failure.
详细描述
Study hypothesis is that preferential left ventricular (LV) pacing, delivered by means of the AdaptivCRT® algorithm and in conjunction with automated V-V delay adjustments, will lead to improvements over standard biventricular pacing (BVP) in the function of all cardiac chambers, reduce arrhythmic burden, improve ventricular-arterial coupling (VAC), and patient functional status. It would be interesting to study what changes in right-side VAC (RVAC) can be appreciated with the activation of the preferential LV pacing algorithm and how they relate to each other, i.e. whether LV is driven towards maximizing output whilst RV shifts to optimizing energy efficiency.
READAPT is a single-center, prospective, randomized trial of heart failure patients eligible for CRT according to current European heart failure guidelines. Informed written consent is required from all study participants.
Adult (aged 18-80 years old), consenting patients with any cardiomyopathy type, diagnosed at least 6 months prior (to exclude recent myocarditis cases that may remit and confound outcomes), on optimal medical therapy for at least 3 months, and an existing I/IIa indication for a cardiac resynchronization therapy - defibrillator (CRT-D) device will be enrolled and randomized into 2 groups, one receiving standard CRT (Group 1 - G1), and one with activation of the preferential LV pacing algorithm (Group 2 - G2). Enrollment date will amount to the baseline assessment date, with device implantation occurring preferably within 48 hours. READAPT will include patients with both new CRT-D implantation and an upgrade from an existing defibrillator or pacemaker with no prior left ventricular lead placement.
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)
盲法说明
Patient and assessor unaware of chosen programming mode and activated algorithms. The standard of care that is biventricular pacing will be provided to all participants.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old Provided informed consent Any cardiomyopathy type, diagnosed at least 6 months prior (to exclude recent myocarditis cases that may remit and confound outcomes) On optimal medical therapy for at least 3 months, An existing I/IIa indication for a CRT-D device Both new CRT-D implantation and an upgrade from an existing ICD or pacemaker with no prior left ventricular lead placement.
排除标准
- •Have an existing Class I recalled lead,
- •Are anticipated to need heart transplantation within the next 9 months,
- •Have undergone cardiac transplantation less than 40 days prior to enrolment,
- •Have had a cerebrovascular accident or transient ischemic attack within 3 months of enrollment,
- •Have had a recent myocardial infarction less than 40 days prior to enrollment, or unstable angina or cardiac revascularization less than 3 months prior to enrolment,
- •Have documented moderate to severe/severe mitral/aortic/tricuspid/pulmonary insufficiency (noninvasive VAC calculation impossible),
- •Exhibit a daily burden of premature ventricular complexes (PVCs) of either ≥10% of total QRSs or ≥10,000 on ambulatory ECG recording21, 22 (to exclude PVC-related, potentially reversible cardiomyopathy),
- •Are currently participating in a clinical investigation that includes an active treatment arm,
- •Have diagnosed pulmonary hypertension other than class II (left heart-related),
- •Have known stage IV-V renal dysfunction (clearance estimated by the Cockcroft-Gault equation),
- •Have permanent atrial fibrillation,
- •Have complete atrioventricular block,
- •Have a prolonged (>200msec) PQ interval on surface ECG (thus invalidating the option for preferential LV pacing),
- •Are pregnant or planning to become pregnant during the duration of the study (in case of unplanned pregnancy the patient will have to be excluded from the study),
- •Have an expected life expectancy of <12 months, or
- •Undergo major adaptations to their pharmacological regimens during follow-up (e.g. initiation of neprilysin inhibitors).
结局指标
主要结局
Changes in patient exercise capacity
时间窗: 12 months
Assessed by cardiopulmonary exercise test in terms of maximal oxygen consumption in ml/kg/min
次要结局
- Left ventricular function(12 months)
- Ventriculoarterial coupling for both systemic and pulmonary circulation(12 months)
- Right ventricular function(12 months)
- Number of hospitalizations for heart failure(12 months)
研究者
Christina Chrysohoou
Cardiology Consultant, Director of Cardiology, Senior Researcher
National and Kapodistrian University of Athens