Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
研究概览
简要总结
This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.
We wish to test the following hypotheses:
- Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
- Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).
详细描述
This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 85
- •All patients with NYHA class II to III congestive heart failure symptoms from ischemic and non-ischemic etiology who received a defibrillator at least 3 months prior to enrollment.
- •All patients with NYHA class III and IV symptoms, QRS complex of the ECG more than 120 ms, who received device for cardiac resynchronization at least 3 months prior to enrollment. These devices are placed when the two ventricles beat at slightly different times. These devices also have the capacity to record arrhythmias as the defibrillators.
排除标准
- •Patients with life expectancy less than 6 months from non-cardiac causes
- •Pregnant women
- •History of major psychosis.
- •Significant chronic liver, renal and pulmonary disease
- •Active alcohol and drug abuse
结局指标
主要结局
Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
时间窗: 3 month interval
Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
时间窗: 3 month intervals
Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.
时间窗: 3 month intervals
Increase in heart rate variability for patients participating in vipassana meditation training.
时间窗: 3 month intervals
次要结局
未报告次要终点