Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?

Conditions
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Congestive Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
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* Behavioral: Vipassana Meditation practice and instruction
* Other: Standard Medical Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Cohort<br>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<br>* 2-3 instructed meditation sessions per week in addition to standard medical care.<br>* Other names: Meditation + ICD;|
| Active Comparator: Standard Care<br>25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health. | Other: Standard Medical Care<br>* Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy