Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Improvement of quality of life
研究概览
简要总结
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.
Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence.
Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.
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
- •Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
- •Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
- •Symptomatic congestive heart failure (NYHA class II-III)
- •Left ventricular systolic dysfunction (LVEF <35%)
- •Optimal medical therapy
- •Sinus rhythm
- •Subjects should be able to perform normal daily activities
排除标准
- •Age <18 or incapacitated adult
- •Documented atrial fibrillation in the last 3 months prior to inclusion
- •Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
- •Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
- •Patients who are unable to tolerate increased pacing rates
- •Indication for cardiac resynchronization therapy
- •Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion
结局指标
主要结局
Improvement of quality of life
时间窗: 3 months after changing the pacing mode
Measured with the Minnesota Living with Heart Failure Questionnaire
次要结局
- Reversibility of chronotropic incompetence(3 months after changing the pacing mode)
- Clinical status(3 months after changing the pacing mode)
- Improvement of functional capacity(3 months after changing the pacing mode)
- Daily activity level(3 months after changing the pacing mode)
研究者
Cornelis P. Allaart
Principal Investigator
Amsterdam UMC, location VUmc