Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
This study has been completed.
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
Uma Srivatsa, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00611260
First received: January 25, 2008
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Congestive Heart Failure Cardiac Resynchronization Therapy |
Behavioral: Vipassana Meditation practice and instruction Other: Standard Medical Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators? |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. [ Time Frame: 3 month interval ] [ Designated as safety issue: No ]
- Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Increase in heart rate variability for patients participating in vipassana meditation training. [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | April 2007 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611260
Locations
| United States, California | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Uma Srivatsa, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Uma Srivatsa, MD, Professor, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00611260 History of Changes |
| Other Study ID Numbers: | 200715089 |
| Study First Received: | January 25, 2008 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Meditation Congestive Heart Failure ICD Cardiac Resynchronization Therapy |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013