Cardiac Resynchronization Therapy, Congestive Heart Failure
Conditions
Keywords
Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy
Brief summary
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: 1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure. 2. 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).
Detailed description
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.
Interventions
BEHAVIORALVipassana Meditation practice and instruction
2-3 instructed meditation sessions per week in addition to standard medical care.
OTHERStandard Medical Care
Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with life expectancy less than 6 months from non-cardiac causes * Pregnant women * Smokers * History of major psychosis. * Significant chronic liver, renal and pulmonary disease * Active alcohol and drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. | 3 month interval |
| Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. | 3 month intervals |
| Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation. | 3 month intervals |
| Increase in heart rate variability for patients participating in vipassana meditation training. | 3 month intervals |
Countries
United States
Outcome results
None listed