Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00611260|
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : May 30, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Cardiac Resynchronization Therapy||Behavioral: Vipassana Meditation practice and instruction Other: Standard Medical Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: Meditation Cohort
25 patients will be given instruction in vipassana meditation. Vipassana meditation is thought to reduce the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure, and improve their overall psychological profile.
Behavioral: Vipassana Meditation practice and instruction
2-3 instructed meditation sessions per week in addition to standard medical care.
Other Name: Meditation + ICD
Active Comparator: Standard Care
25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.
Other: Standard Medical Care
Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
Other Name: Standard of Care
- Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. [ Time Frame: 3 month interval ]
- Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. [ Time Frame: 3 month intervals ]
- Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation. [ Time Frame: 3 month intervals ]
- Increase in heart rate variability for patients participating in vipassana meditation training. [ Time Frame: 3 month intervals ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611260
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Uma Srivatsa, MD||University of California, Davis|